Phase 2 clinical trial results have also shown that elafibranor may be an effective treatment for PBC, a. Harrison SA, Guy CD, Bashir M, et al. Genfit chief operating officer Dean Hum said: "The initiation of a Phase II trial of elafibranor in paediatric NASH is a landmark study, as to our knowledge there has been no other molecule that has shown clinical evidence in a Phase IIb adult NASH trial and then progressed to clinical evaluation in the paediatric NASH setting. The Genfit RESOLVE-IT clinical research study is being done to learn whether an oral investigational medication called elafibranor is safe and effective in treating and preventing disease progression and complications in patients who have nonalcoholic steatohepatitis (NASH) with fibrosis. 52 The protocol-defined primary outcome was reversal of NASH on histologic NAS scoring with resolution of steatosis, ballooning, or. In the Phase 2b trial, GFT505/Elafibranor or a placebo was administered to patients with a histological diagnosis of NASH. ABOUT NASH “NASH” is a liver disease characterized by an accumulation of fat (lipid droplets), along with inflammation and degeneration of hepatocytes. 7Billion) in spite its Phase IIb trial to treat NASH had failed to meet the primary endpoint. Elle pourrait ainsi devenir la première molécule approuvée capable d’éliminer la cause sous-jacente de progression de la NASH. 16 Figure 2: NASH total market value across the US and five major EU markets, by country, 2018−27 Late-phase trials of elafibranor for NASH 169 Table 47. Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial ("RESOLVE-IT") as a potential treatment for NASH, and GENFIT plans to initiate a Phase 3 clinical trial in PBC later this year following its positive Phase 2 results. The Principal Investigator, a prominent liver physician, and we believe that this is a sufficiently long period of time to show an effect on fibrosis given the results and treatment time of the Phase 1 trial. GFT505 improves insulin sensitivity and early studies indicate it may be useful in non-alcoholic fatty liver disease which is being tested in a Phase IIb study. Acute incubation of podocytes and HK-2 cells with elafibranor or recombinant SIRT1 reversed the HFD-sera-induced oxidative stress, autophagy dysfunction, cell apoptosis, barrier marker loss, albumin endocytosis, and reuptake reduction. Despite the fine analysis of the results published in the journal Gastroenterology, a year later, that clearly presents the study as a success, despite the fact that by applying the new definition of reversion of NASH proposed by the FDA after design of the study, phase 2b of ELAFIBRANOR is a success without any statistical reprocessing. In Golden neither 80mg nor 120mg of elafibranor beat placebo in terms of the primary endpoint of Nash resolution without fibrosis worsening, determined by Nash score and 12-month biopsies (Behind the management smokescreen, Genfit study is still a fail, March 27, 2015). The Principal Investigator, a prominent liver physician, and we believe that this is a sufficiently long period of time to show an effect on fibrosis given the results and treatment time of the Phase 1 trial. This is an American Liver Foundation sponsored Support Group providing answers to questions about testing, treatment, and where to turn for help. The Phase 2a twelve-week, multicenter, randomized, double-blind, placebo. T here is a race underway to develop treatments for the fatty liver disease known as NASH. To evaluate the effect of Elafibranor compared to placebo on liver histology in nonalcoholic steatohepatitis (NASH) subjects by assessing the following endpoint: The proportion of Elafibranor treated patients relative to placebo achieving improvement of liver fibrosis of at least one stage. Non-alcoholic fatty liver disease (NAFLD) is one of the most prominent forms of chronic liver disease. The pipeline includes the development of semicarbazide‐sensitive amine. Additionally, in both the NASH Phase 2 study, and a second positive Phase 2 clinical study in patients with heterozygous familial hypercholesterolemia (Phase 2 HeFH Results Press Release), significant reductions in multiple atherogenic lipids were observed. Its most advanced drug candidate, elafibranor, is currently evaluated in pivotal Phase 3 clinical trial ("RESOLVE-IT") as a potential treatment for nonalcoholic steatohepatitis, or NASH. • Viking anticipates data from the ongoing Phase 2 study of VK2809 in fatty liver disease in the first half of 2018, and to initiate a human proof-of-concept study in GSD Ia in the second half of 2017. FDA authenticates study protocol, giving go-ahead for GENFIT to begin a Phase II clinical trial in pediatric NASH. Correction - GENFIT: Unblinding of Phase 3 RESOLVE-IT Data Deferred. Dean Hum, Ph. Tobira recently announced positive results from a phase 2 study of CVC in treating NASH; the experimental drug will move into a late-stage study in 2017. Elafibranor (INN, code name GFT505) is an experimental medication that is being studied and developed by Genfit for the treatment of cardiometabolic diseases including diabetes, insulin resistance, dyslipidemia, and non-alcoholic fatty liver disease (NAFLD). Elafibranor is currently the only late-stage, Phase 3 therapy undergoing investigation for “NASH resolution without the worsening of fibrosis”. Drug Mechanism of Action Study Population Trial Primary Endpoint(s) Elafibranor PPAR α/δ agonist[1] NASH with fibrosis RESOLVE-IT[2] Resolution of NASH w/o fibrosis worsening Obeticholic acid FXR agonist (bile acid)[3] NASH with fibrosis REGENERATE[4,5] Improvement in fibrosis w/o NASH worsening; improvement in NASH w/o fibrosis worsening. Elafibranor has shown promising results for the treatment of PBC in a Phase 2 clinical trial, and was granted the Breakthrough Therapy Designation by the FDA in this indication. Les résultats d’une étude clinique de Phase 2 ont également démontré qu’elafibranor pourrait être un traitement efficace dans la PBC, maladie rare du foie. But the drug missed the mark in a phase 2 study in NASH, which Genfit said was a result of recruiting too many patients with early-stage NASH. Most of the potential treatments for NASH are under investigation in phase II studies, with some at phase I. Discovering and developing drug candidates and diagnostic solutions targeting liver diseases with high unmet needs. What’s next Pharmaxis telegraphed earlier this week that a decision had been made in Germany on the treatment , but a trading halt on Monday rather than a positive announcement suggested bad news was in the wings. Non-alcoholic fatty liver disease (NAFLD) is one of the most prominent forms of chronic liver disease. Gilead Announces Phase 2 Results for GS-0976 in Nonalcoholic Steatohepatitis (NASH) - Oral ACC Inhibitor Led to Significant Reductions in Measures of Liver Fat and Fibrosis - - Results from the GS-0976 Phase 2 Study and 18 Other Abstracts from Across Gilead’s Liver Fibrosis Pipeline Presented at The Liver Meeting ® 2017 -. A phase 2 trial of Genfit’s elafibranor in primary biliary cholangitis has hit its primary endpoint. Elafibranor is GENFIT's lead compound currently under evaluation in RESOLVE-IT, a Phase 3 clinical trial in NASH, and following the positive Phase 2 results in PBC, will be evaluated in a Phase. Pts with biopsy-confirmed NASH, stage 2-3 fibrosis (Planned N = 2065) Obeticholic acid 25 mg/day. The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis. The experimental drug failed to produce significant improvement in NASH symptoms. The primary endpoint of significant NASH resolution without a worsening of fibrosis compared to placebo wasn't. Conshohocken, PA – December 6, 2017 – Madrigal Pharmaceuticals, Inc. Elafibranor is an agonist of the peroxisome proliferator-activated receptor-α (PPAR-α) and peroxisome proliferator-activated receptor-δ (PPAR-δ) with EC 50 values of 45 and 175 nM, respectively. Elafibranor has experienced mixed results in its Phase IIb GOLDEN trial due to the inclusion of non-alcoholic steatohepatitis (NASH) patients with Non-Alcoholic Fatty Liver Disease Activity Score (NAS) of 3 or above, rather than 4, which is usually required for NASH trials. Pharmaxis Development Pipeline for Fibrosis and NASH Intercept Obeticholic acid FXR agonist Phase III Genfit Elafibranor PPAR α/δ agonist Phase III Galmed Aramchol pathways in NASH. The primary outcome measures of this study include the proportion of elafibranor. Elafibranor is an agonist of the peroxisome proliferator−activated receptor-α and peroxisome proliferator−activated receptor-δ. Elafibranor, OCA, CVC, and SEL are four of the drugs undergoing phase III RCTs. Whether these agents have an adjunctive role in the treatment of NASH is now being explored with a number of drugs that target PPAR α, among other PPARs. NASH is defined as the most common form of Nonalcoholic fatty liver disease (NAFLD). Males or females aged from 18 to 75 years inclusive at first screening visit. NORCROSS, Ga. GENFIT: Major Milestone achieved with full recruitment of the Phase 2 trial evaluating elafibranor in PBC. Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial ("RESOLVE-IT") as a potential treatment for NASH, and GENFIT plans to initiate a. Elafibranor a atteint le critère recommandé par la FDA de « résolution de la NASH sans aggravation de la fibrose » ; ce qui correspond au critère. Elafibranor was tested in the phase 2b GOLDEN-505 trial (NCT01694849) which randomized 276 patients with NASH without cirrhosis to Elafibranor 80mg, 120mg or placebo groups for 52 weeks [4]. The randomized, double-blind, placebo-controlled, multi-center Phase 2 study enrolled 125 patients 18 years of age and older with liver biopsy-confirmed NASH and included approximately 25 clinical sites in the United States. Additionally, the Company's oral abstract of the Phase 2 ARREST study has been selected by the American Association for the Study of Liver Diseases for inclusion in The Best of The Liver Meeting 2018. Elafibranor is currently the only late-stage, Phase 3 therapy undergoing investigation for “NASH resolution without the worsening of fibrosis”. co/a37g3XxZ3d". Subjects will be randomly assigned to 1 of 2 treatment groups (TVB- 2640 at one of two doses or placebo). RESOLVE-IT is a phase 3 study evaluating the efficacy and safety of elafibranor 120mg versus placebo in patients with nonalcoholic steatohepatitis (NASH) and fibrosis. had said it expected its elafibranor to win approval Gilead Sciences recently reported phase 2 data on its. The results showed reductions of serum 7a-C4 levels ranging from 74% to 91% across TERN-101 dose groups. feb 24 (reuters) - ngm biopharmaceuticals inc: * ngm bio announces positive preliminary topline liver histology and biomarker data from 24-week phase 2 study (cohort 4) of aldafermin in nash. The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis. The results recently published by GENFIT on PBC (phase 2) are amazing and show a clear action of Elafibranor on Liver. The trial enrolled 47 patients and is designed to assess the safety and efficacy of once daily elobixibat over a period of 16 weeks. 92 liver signal in a chronic liver condition such as NASH. If we limit the examination of the NASH pipeline to drugs that have advanced to phase 3 stages of trials in the United States, we are left with only 3 agents: obeticholic acid (OCA), elafibranor, and aramchol. RESOLVE-IT is a phase 3 study evaluating the efficacy and safety of elafibranor 120mg versus placebo in patients with nonalcoholic steatohepatitis (NASH) and fibrosis. The RESOLVE-IT Study. The primary objectives of this study are to evaluate the effect of elafibranor (120 mg/day) treatment in NASH patients (NAS ≥ 4) with stage 2/3 fibrosis compared to placebo on (1) histological. Can Inventiva's pan-PPAR agonist, lanifibranor, challenge Genfit's elafibranor and Zydus' saroglitazar? What potential do KOLs think PPARs have in NASH? How is the Phase II data for Conatus' emricasan perceived by KOLs? What do they say about the designs of ENCORE-PH and ENCORE-NF Phase II studies for the agent?. Elafibranor a atteint le critère recommandé par la FDA de « résolution de la NASH sans aggravation de la fibrose » ; ce qui correspond au critère. Elafibranor Completed Phase 2 Trials for Non-Alcoholic Steatohepatitis (NASH) Treatment. A new blood test, NT-2, was recently derived and internally validated for assessing the severity of nonalcoholic steatohepatitis (NASH) in a large population of patients with NAFLD. NewsSee all news. Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial ("RESOLVE-IT") as a potential treatment for NASH, and GENFIT plans to initiate a Phase 3 clinical trial of elafibranor in PBC in 2020, following its positive Phase 2 results. That upcoming data drop […]. ClinicalTrials. Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial (“RESOLVE-IT”) as a potential treatment for NASH, and GENFIT plans to initiate a Phase 3 clinical trial of elafibranor in PBC in 2020, following its positive Phase 2 results. Lille, France-based Genfit said Thursday that it had delayed unblinding of data from the Phase III RESOLVE-IT study of elafibranor in NASH as it awaits comments from the Food and Drug. Genfit as well as 2 others have the most promise from my POV. Elafibranor successfully meets primary endpoint with high statistical significance of p<0. Research type. Elafibranor, a PPAR alpha/delta agonist, is currently the only late-stage, Phase 3 (RESOLVE-IT) therapy undergoing investigation for “NASH resolution without the worsening of fibrosis” (approved regulatory endpoint for Phase 3 trials), and could be the first therapy able to eliminate the underlying cause of NASH disease progression. Non-alcoholic steatohepatitis (NASH) results from inflammation and hepatocyte injury in the setting of hepatic steatosis. --(BUSINESS WIRE)-- Arrowhead Pharmaceuticals Inc. RESOLVE-IT est une étude de Phase 3 évaluant l’efficacité et la sécurité d’elafibranor 120 mg versus placebo chez des patients atteints de stéatohépatite non-alcoolique (NASH) et de. Frenette, MD: NASH is becoming a very common cause of liver cancer in the United States. The company now is in its Phase 3 trial to evaluate the safety and effectiveness of obeticholic acid or OCA for people with advanced-stage NASH. Phase III Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Elafibranor (GFT-505) in Patients with Nonalcoholic Steatohepatitis (NASH) and fibrosis 72 week trial includes NASH patients with F1-F3 fibrosis on liver biopsy within six months of screening (biopsy can be completed as part of screening process. Future pharmacotherapy for non-alcoholic steatohepatitis (NASH): Review of phase 2 and 3 trials. FOR IMMEDIATE RELEASE. Until 2 weeks ago, the understanding was, that a decrease of ? 2 points in the total NAS score, regardless of what component was being scored, indicated improvement of NASH. Non-alcoholic steatohepatitis (NASH) represents a subgroup of patients with steatosis and necro-inflammation with or without fibrosis. This is a multicentre, multinational, randomised, double-blind study comparing the efficacy and safety of Elafibranor to a placebo in patients with NASH. Patients continued to receive ursodeoxycholic acid. GENFIT Launches a Phase 2 Trial Evaluating Elafibranor on Hepatic Lipid Composition for NAFL. ¹ These diseases are common in HIV patients and the prevalence is 35% to 40%² The progression of the pathology is characterized by the development of fibrosis that is present in about 20% of. with NASH along with a phase 3 clinical program in a. Now, elafibranor is being further examined in RESOLVE-IT (Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis), but no results have been posted at press time. Phase 2 clinical trial results have also shown that elafibranor may be an effective treatment for PBC, a. This is an American Liver Foundation sponsored Support Group providing answers to questions about testing, treatment, and where to turn for help. A phase 2 trial of Genfit's elafibranor in primary biliary cholangitis (PBC) has hit its primary endpoint. Gilead pushes on with NASH drug after phase 2 success which has a phase 3 trial underway on its NASH drug hopeful, elafibranor, with results also expected next year Gilead also announced. Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial ("RESOLVE-IT") as a potential treatment for NASH, and GENFIT plans to initiate a. Poster Competition – closing date 17th January. NASH can also result in advanced fibrosis, NASH cirrhosis, and NASH Decompensated Cirrhosis. We are evaluating our most advanced drug candidate, elafibranor, in a pivotal Phase 3 clinical trial as a potential treatment for nonalcoholic steatohepatitis, or NASH, and as a potential treatment for primary biliary cholangitis, or PBC. Elafibranor is a peroxisome proliferator-activated receptor alpha/delta agonist that achieved significant biopsy-proven reversal of NASH in moderate- or severely affected patients in the phase 2 GOLDEN study. Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial (“RESOLVE-IT”) as a potential treatment for NASH, and GENFIT plans to initiate a. Elafibranor has shown promising results for the treatment of PBC in a Phase 2 clinical trial, and was granted the Breakthrough Therapy Designation by the FDA in this indication. CytoDyn has also received an approval for a Phase 2 protocol in Metastatic Colon Cancer. Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial (“RESOLVE-IT”) as a potential treatment for NASH, and GENFIT plans to initiate a Phase 3 clinical trial in PBC later this year following its positive Phase 2 results. 16 Figure 2: NASH total market value across the US and five major EU markets, by country, 2018−27 Late-phase trials of elafibranor for NASH 169 Table 47. Son candidat médicament le plus avancé, elafibranor, est actuellement en cours d’évaluation dans une étude clinique pivot internationale de phase 3 (« RESOLVE-IT ») comme traitement potentiel de la NASH, et GENFIT prévoit, à la suite des résultats positifs de Phase 2, d’initier un essai clinique de Phase 3 évaluant elafibranor. January 23, 2019, South San Francisco Second Genome, Inc. After all, the Nash trial's odds of success are low, given elafibranor's phase II flop, the failure of most other Nash projects and the discontinuation of Cymabay's similarly acting seladelpar. In Golden neither 80mg nor 120mg of elafibranor beat placebo in terms of the primary endpoint of Nash resolution without fibrosis worsening, determined by Nash score and 12-month biopsies (Behind the management smokescreen, Genfit study is still a fail, March 27, 2015). If we limit the examination of the NASH pipeline to drugs that have advanced to phase 3 stages of trials in the United States, we are left with only 3 agents: obeticholic acid (OCA), elafibranor, and aramchol. Now, elafibranor is being further examined in RESOLVE-IT (Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis), but no results have been posted at press time. the full poster is here. Intercept's Phase 3 REGENERATE trial for the FXR agonist obeticholic acid is also ongoing, focused on participants with NASH and stage 2 or 3 fibrosis. November 9th 2018 — Consistent with previously presented 3 mg data, 1 mg doses of NGM282 showed rapid and robust impact on fibrosis stage and disease activity as measured by NAS —. FDA accepts study protocol, providing green light for GENFIT to initiate. A Phase 3 clinical trial for PBC should be initiated this year, also following a positive Phase 2 trial. In Europe prevalence of NAFLD is 20-30% and NASH is 5% [1]. D, Chief Operating Officer of GENFIT, added: "The initiation of a Phase 2 trial of elafibranor in pediatric NASH is a landmark study, as to our knowledge there has been no other molecule that has shown clinical evidence in a Phase 2b adult NASH trial and then progressed to clinical evaluation in the pediatric NASH setting. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients with Nonalcoholic Steatohepatitis (NASH) and fibrosis. Subjects will be randomly assigned to 1 of 2 treatment groups (TVB- 2640 at one of two doses or placebo). The company plans to release data from its Phase III study during the first quarter of this year, with an eye on. Such delays are likely a reflection of the relatively low awareness of NASH, the low diagnosis rates, the asymptomatic nature of the disease, and the reluctance of patients to undergo liver biopsy. 7Billion) in spite its Phase IIb trial to treat NASH had failed to meet the primary endpoint. Elafibranor Phase 2 results for treating NASH wasn't what Genfit had planned for —apparently the primary endpoint of significant NASH resolution without a worsening of fibrosis compared to placebo wasn't achieved. A Phase 3 clinical trial for PBC should be initiated this year, also following a positive Phase 2 trial. Icosabutate has been found safe and effective in two prior phase 2 clinical studies for treatment of hypertriglyceridemia and is currently in clinical development for NASH; a phase 2b study was commenced in July 2019 (ICONA) to study the efficacy of icosabutate in NASH. Enrolment for Genfit's Phase II trial of elafibranor has experienced delays (Genfit press release, April 24, 2017). Genfit is set to release interim phase 3 NASH this year. Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial ("RESOLVE-IT") as a potential treatment for NASH, and GENFIT plans to initiate a. cenicriviroc 150 mg daily § Interim subpart H endpoint: Fibrosis reduction at 12 months § Clinical outcome composite ~5 years § Anticipated interim 2020?. Bloomberg the Company & Its Products Bloomberg Anywhere Remote Login Bloomberg Anywhere Login Bloomberg Terminal Demo Request. Overall, the primary endpoint of a 2-point improvement in Nonalcoholic Fatty Liver Disease Activity Score without worsening of fibrosis wasn’t statistically significant for OCA versus placebo. A phase III RCT is enrolling patients with NASH to assess the effects of CVC (150 mg/day or placebo) on liver fibrosis (NCT03028740/AURORA). Interestingly, Genfit's pivotal Phase 3 clinical trial design of elafibranor in NASH has incorporated all the above guidelines and surprisingly did not follow Intercept. - Portefeuille décliné en 5 grands programmes : le GFT505 ou elafibranor, en phase III d’essais cliniques dans la NASH, 2 programmes de biomarqueurs sur le diabète de type 2, un programme sur. This trial was a multicenter (US and Europe), double-blind, randomized, placebo-controlled, 12-week treatment, Phase 2 study to evaluate the efficacy and safety of elafibranor (80 mg and 120 mg once-daily) in adult patients with PBC who had an inadequate response to ursodeoxycholic acid (UDCA). The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis. Elafibranor is GENFIT's lead compound currently under evaluation in RESOLVE-IT, a Phase 3 clinical trial in NASH, and following the positive Phase 2 results in PBC, will be evaluated in a Phase. Albireo Pharma (NASDAQ:ALBO) completed patient enrollment in its Phase 2 trial of elobixibat for the treatment of nonalcoholic steatohepatitis (NASH) and nonalcoholic fatty liver disease (NAFLD). Can Inventiva's pan-PPAR agonist, lanifibranor, challenge Genfit's elafibranor and Zydus' saroglitazar? What potential do KOLs think PPARs have in NASH? How is the Phase II data for Conatus' emricasan perceived by KOLs? What do they say about the designs of ENCORE-PH and ENCORE-NF Phase II studies for the agent?. Results from a Phase 3 study in patients with NASH is expected in the fourth quarter 2019. HistoIndex's Second Harmonic Generation (SHG) Technology: A Potentially Important Tool Used In Madrigal's Phase 2 Nonalcoholic Steatohepatitis (NASH) Clinical Trial SINGAPORE,  Dec. Some thoughts and information about NASH as related to CYDY (some of the text below is cut-and-paste from several relevant articles): In September 2016 Allergan paid an upfront payment of $28. Lomb, PhD Senior Consultant, Defined Health Brent A. with NASH along with a phase 3 clinical program in a. In October 2016, the first patient was treated in the ongoing Phase 2 trial of MGL-3196 for the treatment of NASH. Overall, the primary endpoint of a 2-point improvement in Nonalcoholic Fatty Liver Disease Activity Score without worsening of fibrosis wasn’t statistically significant for OCA versus placebo. Elafibranor is a peroxisome proliferator-activated receptor alpha/delta agonist that achieved significant biopsy-proven reversal of NASH in moderate- or severely affected patients in the phase 2 GOLDEN study. In March, they began their first Phase 3 clinical trial, with a primary endpoint being NASH resolution. Dean Hum, Ph. NGM282 FGF19 analogue phase 2 trial *NAS ≥4 (≥1 in each component), stage 1–3 fibrosis , absolute LFC ≥8% (MRI-PDFF) Defined as ≥1 stage fibrosis improvement, ≥2-point decrease in NAS or resolution of NASH. The phase 3 RESOLVE IT trial is underway. using a TRβ agonist for NASH was that it would only affect lipid levels and not fibrosis, which is clearly not the case. Zydus announces positive results from EVIDENCES IV Phase 2 clinical trial of Saroglitazar Magnesium in NAFLD and NASH Ahmedabad, India, 02 October 2019 • EVIDENCES IV trial meets primary efficacy end-points • Statistically significant 44. A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Nonalcoholic Steatohepatitis (NASH) and Fibrosis (GFT505-315-1) (IRB no. A 12 week randomized trial of twenty pediatric patients to be started at United States medical centers specializing in NASH. Non-alcoholic steatohepatitis, or NASH, is a silent but severe. , a clinical-stage company focused on the development of novel therapeutics identified through microbiome science, today announced that the first patient has been dosed in a Phase 2 clinical trial evaluating SGM-1019 for the treatment of nonalcoholic steatohepatitis (NASH). 5 • Here we report the 24-week interim results of a 48-week phase 2 study investigating the safety, tolerability and efficacy of volixibat in adults with NASH. Although Genfit has already suffered a setback in the area after elafibranor failed a phase 2 trial in 2015, and Evaluate Pharma analysts have said hopes for the drug's success in NASH are already low. Now, elafibranor is being further examined in RESOLVE-IT (Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis), but no results have been posted at press time. The GLP-1 class of drugs were originally developed for diabetes. Obeticholic acid 10 mg/day. The study randomized 80 participants to receive weekly subcutaneous doses of AKR-001 or placebo for up to 16 weeks, with safety and tolerability followed through week 20. Elafibranor is currently the only late-stage, Phase 3 therapy undergoing investigation for “NASH resolution without the worsening of fibrosis”. Financial Government Solutions Legal Reuters News Agency Risk Management Solutions Tax & Accounting Blog: Answers On Innovation @ Thomson Reuters. markers or imaging to assess early inflammation and fibrosis effect increased ability to properly dose range Efficacy endpoints based on Non-invasive markers -No Bx 2-6 wks studies. Phase 2 trial was basis for phase 3 (stage 2,3 fibrosis; 36 weeks) Thyroid hormone receptor βagonist MAESTRO-NASH Phase 3 Trial § NASH with fibrosis stage 1a, 1b, 2, 3 with NAS ≥4 and score of at least 1 in all 3 components § N=2000 § Placebo vs. ARREST is a multicenter, Phase 2b, randomized, double blind, placebo-controlled study designed to evaluate the efficacy and safety of two Aramchol doses (400 and 600 mg tablets) in patients with NASH confirmed by liver biopsy who were overweight or obese and who were pre- diabetic or type II diabetic. Les résultats d’une étude clinique de Phase 2 ont également démontré qu’elafibranor pourrait être un traitement efficace dans la PBC, maladie rare du foie. Cenicriviroc has followed a similar path, with a phase 2b leading to a phase 3 study. 4 Additionally, there are 7 NASH pipeline products with active phase 2 programs that have earned Fast Track designation from the FDA for. Males or females aged from 18 to 75 years inclusive at first screening visit. So far, it has shown to cause positive effects on the two main characteristics of the disease, i. had said it expected its elafibranor to win approval Gilead Sciences recently reported phase 2 data on its. The experimental drug failed to produce significant improvement in NASH symptoms. In the phase 2 trial, patients in the placebo group who switched to treatment demonstrated fibrosis improvement without worsening of NASH compared with placebo (24% vs. Obeticholic Acid for NASH and Fibrosis Double-blind, placebo-controlled, randomized, multicenter phase III trial. 90 should institute an appropriate plan to monitor liver safety early in drug development. FOR IMMEDIATE RELEASE. D, Chief Operating Officer of GENFIT, added: "The initiation of a Phase 2 trial of elafibranor in pediatric NASH is a landmark study, as to our knowledge there has been no other. Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial ("RESOLVE-IT") as a potential treatment for NASH, and GENFIT plans to initiate a Phase 3 clinical trial of elafibranor in PBC in 2020, following its positive Phase 2 results. Gilead Sciences experienced a setback this year with its NASH program, when it canceled development of simtuzumab. facettes de la NASH telles que l’inflammation, la sensibilité à l’insuline, les profils lipidique et métabolique et les marqueurs du foie. Novo Nordisk and Eli Lilly each have similar drugs in Phase 2 NASH trials, called. A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Nonalcoholic Steatohepatitis (NASH) and Fibrosis (GFT505-315-1) (IRB no. NASH is defined as the most common form of Nonalcoholic fatty liver disease (NAFLD). Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial ("RESOLVE-IT") as a potential treatment for NASH, and GENFIT plans to initiate a Phase 3 clinical trial in PBC later this year following its positive Phase 2 results. GENFIT: Positive Phase 2 Results from Study of Elafibranor in Primary Biliary Cholangitis - read this article along with other careers information, tips and advice on BioSpace. Now, elafibranor is being further examined in RESOLVE-IT (Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis), but no results have been posted at press time. Elafibranor is also being evaluated in a Phase 2 study in Primary Biliary Cholangitis (PBC), a rare liver disease. Researchers randomly assigned 276. D, Chief Operating Officer of GENFIT, added: "The initiation of a Phase 2 trial of elafibranor in pediatric NASH is a landmark study, as to our knowledge there has been no other molecule that has shown clinical evidence in a Phase 2b adult NASH trial and then progressed to clinical evaluation in the pediatric NASH setting. Clinical Research Trials: Nonalcoholic Fatty Liver Diseases (NASH) Nonalcoholic Fatty Liver Diseases (NASH) 1. The readout sets Genfit up to start a pivotal trial in PBC and thereby expand its late-phase pipeline beyond NASH. Elafibranor has experienced mixed results in its Phase IIb GOLDEN trial due to the inclusion of non-alcoholic steatohepatitis (NASH) patients with Non-Alcoholic Fatty Liver Disease Activity Score (NAS) of 3 or above, rather than 4, which is usually required for NASH trials. Other drugs in the pipeline include Elafibranor from Genfit, which would be the second drug to hit the market. The increase in the global prevalence of NASH (Non-Alcoholic Steatohepatitis) has turned into an epidemic, urgently requiring effective therapies. 15 Dec 2016; Privately held Cirius and NGM and big pharma Bristol-Myers Squibb are in Phase II for NASH with programs also working to validate non-invasive biomarkers for diagnosis, prognosis and treatment impact. VK2809 successfully achieved primary and secondary endpoints in a Phase 2 study for the treatment of patients with elevated LDL-C and non-alcoholic fatty liver disease (NAFLD). (2:1) Phase 3 trial, conducted in approximately 1800 patients, at 200 centers worldwide. Elle pourrait ainsi devenir la première molécule approuvée capable d’éliminer la cause sous-jacente de progression de la NASH. Future Pharmacotherapy for Non-alcoholic Steatohepatitis (NASH): Review of Phase 2 and 3 Trials. There are NASH products in the pipeline. com/pipeline/elafibranor/ (2019, November 11). It is the first set of exposure-response studies in patients, and is carried out before beginning Phase 2B (the patient dose-ranging trial) and Phase 3 (clinical efficacy-safety studies). Drug Mechanism of Action Study Population Trial Primary Endpoint(s) Elafibranor PPAR α/δ agonist[1] NASH with fibrosis RESOLVE-IT[2] Resolution of NASH w/o fibrosis worsening Obeticholic acid FXR agonist (bile acid)[3] NASH with fibrosis REGENERATE[4,5] Improvement in fibrosis w/o NASH worsening; improvement in NASH w/o fibrosis worsening. Most of the potential treatments for NASH are under investigation in phase II studies, with some at phase I. Elafibranor is a new generation dual PPAR (PPAR-α, δ) agonist and Phase 3 hepatic drug candidate in clinical trial for therapeutic efficacy in NASH. 42 Elafibranor was well tolerated, at both doses; at a dose of 120 mg, elafibranor was effective on NASH resolution without worsening of fibrosis in patients with an. A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80 mg and 120mg after 12 Weeks of Treatment in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid. The youngest woman ever elected to the United States Congress, Democrat Alexandria Ocasio-Cortez, is a force to contend with. The trial population also saw significant improvements in other secondary cardiometabolic endpoints over the course of the one year study, across various levels of NAFLD, NASH, and fibrosis. Gilead pushes on with NASH drug after phase 2 success which has a phase 3 trial underway on its NASH drug hopeful, elafibranor, with results also expected next year Gilead also announced. Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial ("RESOLVE-IT") as a potential treatment for NASH, and GENFIT plans to initiate a Phase 3 clinical trial in PBC later this year following its positive Phase 2 results. D, Chief Operating Officer of GENFIT, added: "The initiation of a Phase 2 trial of elafibranor in pediatric NASH is a landmark study, as to our knowledge there has been no other molecule that has shown clinical evidence in a Phase 2b adult NASH trial and then progressed to clinical evaluation in the pediatric NASH setting. , 30 million people are suffering from a form of fatty liver disease that progresses into a form of liver cirrhosis that eventually leads to death, unless a patient can receive a liver. Submit your entry prior to the closing deadline (1 entry per person) Two entries will be selected by the judges. Dean Hum, Ph. Non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) are the leading cause of liver disease. Obeticholic acid is an FDA-designated breakthrough therapy, and the study is expected to complete in October 2022, with an interim analysis before the end of this year. The readout sets Genfit up to start a pivotal trial in PBC and thereby expand its late-phase pipeline beyond NASH. A phase III RCT is enrolling patients with NASH to assess the effects of CVC (150 mg/day or placebo) on liver fibrosis (NCT03028740/AURORA). 3M — will be invested in completing a phase III trial testing Genfit’s core drug, called elafibranor, as a treatment for non-alcoholic steatohepatitis (NASH). 52 The protocol-defined primary outcome was reversal of NASH on histologic NAS scoring with resolution of steatosis, ballooning, or. Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial (“RESOLVE-IT”) as a potential treatment for NASH, and GENFIT plans to initiate a. 1, 2 NAFLD has a histological spectrum that ranges from the relatively benign nonalcoholic fatty liver (NAFL), to the aggressive form of nonalcoholic steatohepatitis (NASH), to NASH with advanced fibrosis/cirrhosis. The compound is currently being evaluated in a Phase 2b clinical trial in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH). The randomized, double-blind, placebo-controlled, multi-center Phase 2 study enrolled 125 patients 18 years of age and older with liver biopsy-confirmed NASH and included approximately 25 clinical sites in the United States. About the Phase 2 NASH Study The randomized, double-blind, placebo-controlled, multi-center Phase 2 study enrolled 125 patients 18 years of age and older with liver biopsy-confirmed NASH and included approximately 25 clinical sites in the United. Genfit chief operating officer Dean Hum said: “The initiation of a Phase II trial of elafibranor in paediatric NASH is a landmark study, as to our knowledge there has been no other molecule that has shown clinical evidence in a Phase IIb adult NASH trial and then progressed to clinical evaluation in the paediatric NASH setting. This phase IIb study will evaluate the efficacy and safety of GFT505 80mg and 120mg once daily for 52 weeks on the. Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial (“RESOLVE-IT”) as a potential treatment for NASH, and GENFIT plans to initiate a Phase 3 clinical trial of elafibranor in PBC in 2020, following its positive Phase 2 results. The treatment was taken for 52 weeks. elafibranor dans la NASH à la suite des résultats positifs de Phase 2, d'initier un essai clinique de Phase 3 évaluant elafibranor dans la PBC dès 2020. NITAZOXANIDE already marketed as a broad-spectrum antiparasitic and broad-spectrum antiviral drug, the NASH rights were acquired by GENFIT who discovered a strong anti fibrotic effect of the compound, a phase 2 trial is in course in USA to confirm that effect. January 23, 2019, South San Francisco Second Genome, Inc. with NASH along with a phase 3 clinical program in a. But the drug missed the mark in a phase 2 study in NASH, which Genfit said was a result of recruiting too many patients with early-stage NASH. Genfit is set to release interim phase 3 NASH this year. by NASDAQ Market News March 11, 2019. Slingshot members are talking to an expert! The topic is: Focusing on Elafibranor's potential, what are your thoughts on the RESOLVE-IT trial and the Phase 2 results that have been publicly. Les résultats d'une étude clinique de Phase 2 ont également démontré qu'elafibranor pourrait être un traitement efficace dans la PBC, maladie rare du foie. Poster Competition – closing date 17th January. A 12 week randomized trial of twenty pediatric patients to be started at United States medical centers specializing in NASH. FDA authenticates study protocol, giving go-ahead for GENFIT to begin a Phase II clinical trial in pediatric NASH. Interestingly, Genfit's pivotal Phase 3 clinical trial design of elafibranor in NASH has incorporated all the above guidelines and surprisingly did not follow Intercept. Final patient randomized in a Phase 2a clinical trial evaluating efficacy and safety of elafibranor in PBC (Primary Biliary Cholangitis), a rare liver disease with unmet needs. (2:1) Phase 3 trial, conducted in approximately 1800 patients, at 200 centers worldwide. Obeticholic Acid for NASH and Fibrosis Double-blind, placebo-controlled, randomized, multicenter phase III trial. The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis. pleted pivotal phase 2 studies, a nd provide a detailed outline of key active studies with trial data for drugs in development, including obeticholic acid, elafibranor, cenicriviroc and selonsertib. NGM Bio's NASH Drug Shows Promise, Shares Rise on Early Phase 2 Data. The Principal Investigator, a prominent liver physician, and we believe that this is a sufficiently long period of time to show an effect on fibrosis given the results and treatment time of the Phase 1 trial. ABOUT NASH. The readout sets Genfit up to start a pivotal trial in PBC and thereby expand its late-phase pipeline beyond NASH. gov is a registry of publicly and privately supported clinical studies involving human participants conducted around the world. Discussing the NASH Drug Development Landscape: How Big is the Opportunity and How Do the Major Drugs in Development Stack Up? Expert Interview. Clinically, elafibranor has been shown to. Get more information about eligibility criteria and enrolling in A Multicenter Randomized Double-Blind Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients with Nonalcoholic Steatohepatitis (NASH) and fibrosis. Research type. Poxel announced positive safety, tolerability and pharmacokinetic results from a phase 1b multiple ascending dose trial of PXL065, a deuterium-stabilized R-stereoisomer of Actos under investigation for nonalcoholic steatohepatitis, according to a press release. But the drug missed the mark in a phase 2 study in NASH, which Genfit said was a result of recruiting too many patients with early-stage NASH. Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial ("RESOLVE-IT") as a potential treatment for NASH, and GENFIT plans to initiate a Phase 3 clinical trial of elafibranor in PBC in 2020, following its positive Phase 2 results. Multiple inflammatory and fibrosis serum biomarkers at 12 and 36 weeks are also being and will be assessed. Cenicriviroc treatment for adults with non-alcoholic steatohepatitis: year 2 analysis of the phase 2b CENTAUR study. The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis. Elafibranor is a new generation dual PPAR (PPAR-α, δ) agonist and Phase 3 hepatic drug candidate in clinical trial for therapeutic efficacy in NASH. Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial ("RESOLVE-IT") as a potential treatment for NASH, and GENFIT plans to initiate a. I spoke to Dean Hum, the current COO and CSO of Genfit, to find out more about the company's 20-year journey and its hopes for the future. Meanwhile, elafibranor (or another drug that proves. , chief medical officer of Terns. Phase 2 clinical trial results have also shown that elafibranor may be. Genfit is set to release interim phase 3 NASH this year. 11 As expected from earlier phase 2 studies,17, 18 including a. Clinical Research Trials: Nonalcoholic Fatty Liver Diseases (NASH) Nonalcoholic Fatty Liver Diseases (NASH) 1. Phase 2 NASH Agent Candidates. ballooning = 0) without worsening of fibrosis Phase 2 Elafibranor 52 w (GOLDEN-505) Ratziu, Francque et al. In Golden neither 80mg nor 120mg of elafibranor beat placebo in terms of the primary endpoint of Nash resolution without fibrosis worsening, determined by Nash score and 12-month biopsies (Behind the management smokescreen, Genfit study is still a fail, March 27, 2015). It is the first set of exposure-response studies in patients, and is carried out before beginning Phase 2B (the patient dose-ranging trial) and Phase 3 (clinical efficacy-safety studies). FDA accepts study protocol, providing green light for GENFIT to initiate Phase 2 clinical trial in pediatric NASH; Elafibranor, the first molecule with positive results on registrational endpoint in Phase 2b clinical trial in adult NASH to be evaluated in pediatric NASH. Elafibranor was tested in the phase 2b GOLDEN-505 trial (NCT01694849) which randomized 276 patients with NASH without cirrhosis to Elafibranor 80mg, 120mg or placebo groups for 52 weeks [4]. RESOLVE-IT is a phase 3 study evaluating the efficacy and safety of elafibranor 120mg versus placebo in patients with nonalcoholic steatohepatitis (NASH) and fibrosis. When inflammation is present, this becomes non-alcoholic steatohepatitis (NASH), which can progress to cirrhosis and hepatocellular carcinoma. com Top Tickers, 2/20/2020. Albireo Pharma (NASDAQ:ALBO) completed patient enrollment in its Phase 2 trial of elobixibat for the treatment of nonalcoholic steatohepatitis (NASH) and nonalcoholic fatty liver disease (NAFLD). 4% over the forecast period, driven by expected approvals of Elafibranor, Obeticholic acid, Simtuzumab and Selonsertib. Ratziu V, et al. 4 Additionally, there are 7 NASH pipeline products with active phase 2 programs that have earned Fast Track designation from the FDA for. Gilead pushes on with NASH drug after phase 2 success which has a phase 3 trial underway on its NASH drug hopeful, elafibranor, with results also expected next year Gilead also announced. The readout sets Genfit up to start a pivotal trial in PBC and thereby expand its late-phase pipeline beyond NASH. Data from Phase 2b trial of GENFIT's Elafibranor published in Gastroenterology. Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial (“RESOLVE-IT”) as a potential treatment for NASH, and GENFIT plans to initiate a Phase 3 clinical trial of elafibranor in PBC in 2020, following its positive Phase 2 results. Elafibranor(GFT505) Powder-The New Drug For NASH Treatment Study What is Elafibranor (GFT505)? Elafibranor (GFT505) powder (923978-27-2), is an experimental drug whose research is still underway. Elafibranor est actuellement la seule thérapie à un stade avancé de développement en Phase 3 à être évaluée sur le critère de « résolution de la NASH sans aggravation de la fibrose ». LYON, France--(BUSINESS WIRE)-- POXEL SA (Euronext: POXEL - FR0012432516), a biopharmaceutical company focused on the development of innovative treatments for metabolic disorders, including type 2 diabetes and non-alcoholic steatohepatitis (NASH), today announced initiation of the Phase 2a program for PXL770, a direct adenosine monophosphate-activated protein kinase activator (AMPK), for the treatment of NASH. These results indicate that TERN-101 has best-in-class potential and gives us great confidence as we prepare to initiate phase 2 clinical studies in NASH patients in mid-2020,” commented Erin Quirk, M. - Portefeuille décliné en 5 grands programmes : le GFT505 ou elafibranor, en phase III d’essais cliniques dans la NASH, 2 programmes de biomarqueurs sur le diabète de type 2, un programme sur. In October 2016, the first patient was treated in the ongoing Phase 2 trial of MGL-3196 for the treatment of NASH. The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis. About Resolve-It RESOLVE-IT is a phase 3 study evaluating the efficacy and safety of elafibranor 120mg versus placebo in patients with nonalcoholic steatohepatitis (NASH) and fibrosis. It is an oral treatment that acts on the 3 sub-types of PPAR (PPARa, PPARg, PPARd) with a preferential action on PPARa. Results from the trial are expected by the end of the year, and the company is also setting aside €13. Gastroenterology. Its most advanced drug candidate, elafibranor, is currently evaluated in pivotal Phase 3 clinical trial ("RESOLVE-IT") as a potential treatment for nonalcoholic steatohepatitis, or NASH. One of the drugs being studied for NASH treatment is Elafibranor(GFT505) powder(923978-27-2). Its most advanced drug candidate, elafibranor, is currently evaluated in pivotal Phase 3 clinical trial (“RESOLVE-IT”) as a potential treatment for nonalcoholic steatohepatitis, or NASH. The two companies will also collaborate on other development programs for liver disease treatments. Such delays are likely a reflection of the relatively low awareness of NASH, the low diagnosis rates, the asymptomatic nature of the disease, and the reluctance of patients to undergo liver biopsy. Eligibility: Inclusion Criteria: 1. The GLP-1 class of drugs were originally developed for diabetes. Allergan has a deal with. Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial (“RESOLVE-IT”) as a potential treatment for NASH, and GENFIT plans to initiate a Phase 3 clinical trial in PBC later this year following its positive Phase 2 results. 5 • Here we report the 24-week interim results of a 48-week phase 2 study investigating the safety, tolerability and efficacy of volixibat in adults with NASH. Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial (“RESOLVE-IT”) as a potential treatment for NASH, and GENFIT plans to initiate a Phase 3 clinical trial of elafibranor in PBC in 2020, following its positive Phase 2 results. Overview of the Clinical Trial Data on Non-alcoholic Steatohepatitis (NASH) Brent A. (NASDAQ: ARWR) today announced that it has dosed the first patients in AROHSD1001, a Phase 1/2 clinical study of ARO-HSD, the company’s investigational RNA interference (RNAi) therapeutic being developed as a treatment for patients. 100% Upvoted. Now, elafibranor is being further examined in RESOLVE-IT (Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis), but no results have been posted at press time. Despite the fine analysis of the results published in the journal Gastroenterology, a year later, that clearly presents the study as a success, despite the fact that by applying the new definition of reversion of NASH proposed by the FDA after design of the study, phase 2b of ELAFIBRANOR is a success without any statistical reprocessing. Phase 2A: A controlled clinical study carried out after completing Phase-1 studies. , ballooning and inflammation. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today announced that a paper highlighting the results of its NASH-CX Phase 2 clinical trial in NASH cirrhosis have been published in the peer-reviewed journal Gastroenterology. Researchers randomly assigned 276. If we limit the examination of the NASH pipeline to drugs that have advanced to phase 3 stages of trials in the United States, we are left with only 3 agents: obeticholic acid (OCA), elafibranor, and aramchol. Elafibranor (INN, code name GFT505) is an experimental medication that is being studied and developed by Genfit for the treatment of cardiometabolic diseases including diabetes, insulin resistance, dyslipidemia, and non-alcoholic fatty liver disease (NAFLD). So far, it has shown to cause positive effects on the two main characteristics of the disease, i. Non-alcoholic steatohepatitis (NASH) represents a subgroup of patients with steatosis and necro-inflammation with or without fibrosis. Elafibranor in NASH. A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Nonalcoholic Steatohepatitis (NASH) and Fibrosis (GFT505-315-1) (IRB no. In the phase 2 trial, patients in the placebo group who switched to treatment demonstrated fibrosis improvement without worsening of NASH compared with placebo (24% vs. In March, they began their first Phase 3 clinical trial, with a primary endpoint being NASH resolution. Although Genfit has already suffered a setback in the area after elafibranor failed a phase 2 trial in 2015, and Evaluate Pharma analysts have said hopes for the drug's success in NASH are already low. The basis for advancing to Phase 3 is the positive effects of GR-MD-02 on HVPG and the possible prevention or postponement of development of esophageal varices in the Phase 2 NASH-CX trial, which we believe is the first large, randomized clinical trial of any drug to demonstrate a clinically meaningful improvement in these patients. Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial ("RESOLVE-IT") as a potential treatment for NASH, and GENFIT plans to initiate a.