Regenerate trial nash Non-alcoholic steatohepatitis, or NASH, is a liver disease in which a build-up of fat in the liver is followed by inflammation and cell damage. Published Even though Intercept's management appeared reassuring about the prospects of OCA in "Western NASH patients", the Phase 3 REGENERATE trial will be conducted in a The phase 3 REGENERATE trial (Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment) is comparing obeticholic acid vs placebo. 2024; 390: 497–509 For more on . MAESTRO-NASH trial. Here, Events: Results from the Phase 3 REGENERATE Trial of Obeticholic Acid for Nonalcoholic Steatohepatitis" Abstract # 33 January 6, 2023; 7:30 a. Simultaneously published in the New England Journal of Medicine, results of the trial indicate REGENERATE is Intercept’s ongoing international Phase 3 trial studying OCA in NASH patients with liver fibrosis. Those in the OCA arm showed statistically significant We would like to show you a description here but the site won’t allow us. 3 People with NASH are also at greater risk of type 2 diabetes and cardiovascular disease. Aramchol: The high-dose group demonstrated a 29. Intercept is developing obeticholic OCA, a farnesoid X receptor agonist, has been demonstrated to reduce hepatic fibrosis without worsening NASH in the 18-month interim analysis of the REGENERATE phase Because this change will affect the trial's conclusions, Intercept will have the panel of pathologists re-review all of the biopsies from its late-stage effort, known as Regenerate. Obeticholic acid failed to demonstrate superiority to placebo for improving fibrosis in patients with compensated cirrhosis due to nonalcoholic steatohepatitis in a phase 3 trial, according to an Intercept Pharmaceuticals’ obeticholic acid (Ocaliva or OCA) failed to treat patients with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH) better than a placebo in a Phase III trial, the company announced Friday. In the phase 3 REGENERATE trial (NCT02548351), (Firsocostat) for the treatment of NASH. Emerging data have revealed that nonalcoholic steatohepatitis (NASH) and fibrosis are associated with the reactivation of developmental pathways in the liver injury response. OCA for liver fibrosis due to NASH, and our clinical trial activities; our After reviewing Intercept's NASH application, came to improvement of fibrosis with no worsening of NASH at 18 months, one of the two primary endpoints of the phase 3 We are currently conducting a pivotal Phase 3 clinical trial of OCA in patients with liver fibrosis due to NASH, known as the REGENERATE trial. Consequently, Resmetirom’s Phase 3 trial focuses primarily on NASH resolution. Results from an ongoing Phase III Conclusions: NASH patients evaluated in REGENERATE had impaired quality of life and underlying pruritus at baseline. Additionally, ~300 patients with stage 1 fibrosis Background Nonalcoholic steatohepatitis (NASH) is a chronic liver disease associated with hepatic morbidity and mortality and extra-hepatic comorbidities. 4 Intercept’s application for approval was based on findings from the Phase III REGENERATE trial, which evaluated Ocaliva in people with diagnosed NASH and mild to advanced fibrosis (Stage F1 to F3). There is a need for specific drugs to treat NASH. 7 June 2021 Obeticholic acid Lance 2019 Younossi Regenerate trial. 1 The study is based on the 18-month interim results from the phase-III REGENERATE trial, in which 931 NASH patients with fibrosis stage F2 or F3 were randomized to receive placebo or two REGENERATE (Randomized Global Phase 3 Study to Evaluate the Impact on NASH with Fibrosis of Obeticholic Acid Treatment) is an ongoing Phase 3, randomized, double-blind, placebo-controlled Data from the Randomized Global Phase 3 Study to Evaluate the Impact on NASH with Fibrosis of Obeticholic Acid Treatment (REGENERATE; NCT02548351) trial of obeticholic acid (OCA) in NASH was used to evaluate NIT‐based OCA efficacy endpoints among patients treated with OCA 25 mg or placebo. 12% placebo, P < 0. , prevent progression to cirrhosis and In accordance with harmonized advice from the FDA and European Medicines Authority (EMA), the Randomized Global Phase 3 Trial to Evaluate the Impact on NASH with Play Stephen Harrison, MD, on the REGENERATE Clinical Trial of Obeticholic Acid for NASH by Podcasts360 on desktop and mobile. obeticholic acid. This double-blind, placebo-controlled trial will administer 10 or 25 mg OCA tablets or placebos to 2,500 patients We aimed to validate the original 18-month liver biopsy analysis from the phase 3 REGENERATE trial of OCA for treatment of NASH with a consensus panel analysis, provide holic Steatohepatitis) trial assessing the efficacy and safety of OCA in compensated cirrhosis due to NASH in 919 randomized patients also failed to meet its primary histological endpoint. A tremendous clinical At one point, OCA—which is currently approved as a treatment for primary biliary cholangitis under the brand name Ocaliva— appeared to be a front-runner in the race to Zobair Younossi, MD, PhD, of Inova Fairfax Medical Campus in Falls Church, Virginia, and colleagues conducted the Phase III REGENERATE trial to evaluate Ocaliva, After reviewing Intercept's NASH application, came to improvement of fibrosis with no worsening of NASH at 18 months, one of the two primary endpoints of the phase 3 The progress, timing, and results of our REGENERATE clinical trial, including the safety and efficacy of obeticholic acid (“OCA”) for the treatment of liver fibrosis due to OCA Obeticholic Acid Update at NASH-TAG Jan 5 2023 AASLD: Topline Results From a New Analysis of the REGENERATE Trial of Obeticholic Acid for the Treatment of Nonalcoholic Rezdiffra, made by Madrigal Pharmaceuticals, is a daily pill that activates a thyroid hormone receptor that reduces liver fat accumulation. In the 18-month interim analysis of an The REGENERATE trial was the first NASH treatment to meet its endpoint; however, two side-effects of the drug reduced enthusiasm for conditional approval. e. During the trial, researchers analyzed obeticholic acid (OCA) as a treatment for patients with nonalcoholic steatohepatitis (NASH). Lipotoxicity, owing to increased delivery of fatty acids to the liver, The proportion of liver transplants attributable to NASH has increased rapidly in past years and by 2020 the disease is projected to become the leading indication for liver transplant. Specifically, a new analysis of the phase 3 REGENERATE trial showed that Ocaliva, given once-daily at 25 mg, helped 22. 4% of patients randomized to once-daily oral OCA 25 mg met the primary endpoint of achieving at least 1 stage of fibrosis improvement with no In July 2022, following new methodology for the reading of biopsy slides from the REGENERATE trial (using a consensus panel approach vs the original single reader The phase III MAESTRO-NASH trial (NCT03900429) In the REGENERATE trial (for OCA), for instance, pruritus was the most frequent AE with up to 50% of patients Introduction Obeticholic acid (OCA), an FXR agonist, improved both fibrosis and histologic features of nonalcoholic steatohepatitis (NASH) in the Ph2 FLINT study. 3 trial ever in NASH and plans to enroll a total of 2,500 patients with an interim histology endpoint at 72 weeks in 1,400 We compared patient characteristics with the inclusion and exclusion criteria used for enrollment in the Randomized Global Phase 3 Study to Evaluate the Impact on NASH with Semantic Scholar extracted view of "Regenerate: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Multicenter Study of Obeticholic Acid Therapy for Nonalcoholic The NDA submission included 2 interim analyses from the phase 3 REGENERATE trial (ClinicalTrials. The investigators of REGENERATE reported Intercept Pharmaceuticals announced that the positive results from the interim analysis of the Phase III REGENERATE study of Ocaliva (obeticholic acid) in the first peer-reviewed publication of positive results from a pivotal study evaluating an investigational therapy for NASH. Screened Population From the REGENERATE Trial Boursier Oral 0056 Evaluation of Obeticholic Acid Efficacy in Patients With NASH Who Were Monitored Using Noninvasive Tests: A Post We aimed to validate the original 18-month liver biopsy analysis from the phase 3 REGENERATE trial of OCA for treatment of NASH with a View A global action agenda for turning the tide on inadequate response or intolerance to ursodeoxycholic acid: 6-month results from a phase 2 trial Poster presentation Presenter: David E. This robust phase 3 study assesses the effect of OCA on liver histology as a surrogate for transplant-free survival and liver-related outcomes, including progression to REGENERATE is a large international trial that randomized close to 2500 patients to receive 25 mg OCA daily, 10 mg OCA daily, or placebo. / REGENERATE Study Investigators. About Abstract: Tremendous effort has been put forth over the past 2 decades in understanding the pathophysiology of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH). 3 trial ever in NASH and plans to enroll a total of 2,500 patients with an interim histology endpoint at 72 weeks in 1,400 Resmetirom is an oral, liver-directed, thyroid hormone receptor beta-selective agonist in development for the treatment of NASH with liver fibrosis. , Lancet, 2019). The trial, named REGENERATE, enrolled participants with moderate to severe liver In this clinical trial of obeticholic acid (OCA) in patients with NASH (REGENERATE), we reaffirmed our previous results demonstrating that OCA was superior to Here we report results from a planned interim analysis of an ongoing, phase 3 study of obeticholic acid for NASH. Lifestyles are rarely enough and for patients with advanced conditions this will not be sufficient. Currently, there are no pharmacological options available for the treatment of non-alcoholic steatohepatitis (NASH). ” There are currently no medications approved for the treatment of NASH. Several drugs with different mechanisms of action are in development to treat NASH. The subsequent phase 3 REGENERATE trial (NCT02548351) reported sufficient antifibrotic efficacy, which was later confirmed by an independent pathological re-analysis Intercept (ICPT) initiates a randomized phase III trial, REVERSE, on obeticholic acid in subjects with compensated cirrhosis due to non-alcoholic steatohepatitis. , wherein they used non-invasive tests (NITs) to evaluate the therapeutic response to obeticholic acid (OCA). Abbreviations: ITT, intent-to-treat; NASH, Intercept Pharmaceuticals announced that the positive results from the interim analysis of the Phase III REGENERATE study of Ocaliva (obeticholic acid) in the first peer Conclusions: NASH patients evaluated in REGENERATE had impaired quality of life and underlying pruritus at baseline. Obeticholic acid (OCA) met its primary endpoint of improvement in liver fibrosis without worsening of nonalcoholic steatohepatitis (NASH), according to topline results from the Here we report results from a planned interim analysis of an ongoing, phase 3 study of obeticholic acid for NASH. In: The Lancet, Vol. In the 18-month interim analysis of an ongoing randomized, placebo-controlled phase 3 trial (REGENERATE), early results demonstrated that obeticholic acid (OCA) 25 mg significantly This Month 18 pre-specified interim analysis of the ongoing Ph3 REGENERATE study evaluated the effect of OCA on liver histology in patients (pts) with biopsy-confirmed NASH. Sanyal, Vlad n engl j med 389;11 nejm. Sanyal1 ,*, month liver biopsy analysis from the phase III The phase III REGENERATE trial (NCT02548351) was conducted in patients with pre-cirrhotic NASH randomized to placebo, OCA 10 mg or 25 mg daily; an 18-month interim analysis was Results from a new efficacy and safety analysis of the REGENERATE trial of obeticholic acid for treatment of pre-cirrhotic fibrosis due to non-alcoholic steatohepatitis. Improvement of NASH corresponded with improvement in In the interim analysis of phase 3 REGENERATE trial, 931 biopsy-proven patients with NASH and fibrosis stages F2-F3 were randomly assigned to receive obeticholic acid 25 mg daily (n=308), Results from a new efficacy and safety analysis of the REGENERATE trial of obeticholic acid for treatment of pre-cirrhotic fibrosis due to non-alcoholic steatohepatitis. month liver biopsy analysis from the phase III REGENERATE trial of OCA for the treatment of NASH with a consensus panel analysis, provide additional histology data in a larger Final end-of-study results from the phase 3 REGENERATE study of obeticholic acid (OCA) for the treatment of pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis The design and endpoints of REGENERATE, an ongoing phase 3 study, further evaluate OCA treatment in patients with fibrosis due to NASH. They were randomly assigned to receive 10 or 25 milligrams of Ocaliva or a placebo once daily. The trial, known as REGENERATE, is expected to enroll approximately 2,000 NASH patients with advanced Based on encouraging phase II data, various drugs like farnesoid X receptor (FxR) agonist, obeticholic acid (OCA) (REGENERATE trial in NASH with F2-3 fibrosis and REVERSE trial in NASH patients Intercept Pharmaceuticals (Nasdaq: ICPT) announced the presentation of two abstracts on obeticholic acid (OCA) at the NASH-TAG Conference 2023, taking place from January 5-7, 2023, in Park City, Utah. Improvement of NASH corresponded with improvement in In September 2015, Intercept initiated its international Phase 3 trial studying OCA in NASH. Hepatology. FLINT found that obeticholic acid (OCA) treatment was associated with improved liver function in 4. OCA for liver fibrosis due to NASH, and our clinical trial activities; our ability to We read with great interest the intriguing and clinically very relevant study by Rinella et al. Intercept also reported analyses from the pivotal Phase III REGENERATE trial where treatment with 25-mg OCA led to “a statistically significant improvement in liver fibrosis Background Nonalcoholic steatohepatitis (NASH) is a chronic liver disease associated with hepatic morbidity and mortality and extra-hepatic comorbidities. Obeticholic Changes REGENERATE (Randomized Global Phase 3 Study to Evaluate the Impact on NASH with Fibrosis of Obeticholic Acid Treatment) is an ongoing Phase 3, randomized, double OCA’s clinical trial for NASH, REGENERATE, will be completed in 2021. In the 931 patient study, investigators found 22. REGENERATE is expected to enroll approximately 2,000 patients at approximately Of those, obeticholic acid is the single agent that demonstrates promise according to the interim analyses of the REGENERATE trial. REGENERATE is BACKGROUND & AIMS: Obeticholic acid (OCA) is a first-in-class farnesoid X receptor agonist and antifibrotic agent in development for the treatment of pre-cirrhotic liver fibrosis due to non United States in the REGENERATE trial were com-pared to data generated from cohorts of healthy adults. Published on: Monday, 28 The demise of seladelpar is another blow to the industry’s hopes of tackling NASH after Gilead’s ASK1 inhibitor related fibrosis in September based on the REGENERATE trial REGENERATE (Randomized Global Phase 3 Study to Evaluate the Impact on NASH with Fibrosis of Obeticholic Acid Treatment) is an ongoing Phase 3, randomized, double OF THE REGENERATE TRIAL 1Quentin Anstee*, 2Kuldip Digpal. N Engl J Med. The data from the second interim analysis of the pivotal Phase 3 REGENERATE study highlight OCA's antifibrotic effects and favorable long-term Treating NASH. We aimed to validate the original 18-month liver biopsy analysis from the phase III REGENERATE trial of OCA for the treatment of NASH with a consensus panel analysis, Background: Non-alcoholic steatohepatitis (NASH) is a common type of chronic liver disease that can lead to cirrhosis. 4% of patients with advanced fibrotic NASH achieve at least one stage of Nevertheless, OCA’s reanalysis in NASH based on 18-month REGENERATE data allows it a clean slate at demonstrating its safety and efficacy. In the recently completed 72-week phase 2 trial, semaglutide treatment (0. Articles. Methods: REGENERATE is a pivotal, long-term study of ~2400 patients with NASH, including ~2100 patients with stage 2 or 3 liver fibrosis. About the Phase 3 REGENERATE Trial REGENERATE is Intercept’s ongoing international Phase 3 trial studying OCA in NASH patients with liver fibrosis. About the REGENERATE Study REGENERATE (Randomized Global Phase 3 Study to Evaluate the Impact The REGENERATE study is the currently recruiting phase III multi-centre, double-blind, randomised, placebo-controlled trial of OCA in patients with NASH. 1% of patients who took 10 mg daily of OCA and 11. placebo in patients with NASH, various NITs were also evaluated. 9 Patients were eligible for inclusion if they were 18 years of age or older and had noncirrhotic NASH (the Specifically, a new analysis of the phase 3 REGENERATE trial showed that Ocaliva, given once-daily at 25 mg, helped 22. Measures it’s taking include winding down a long-term patient outcomes follow-up of the phase 3 REGENERATE study for Ocaliva in NASH. Simultaneously published in the New England Journal of Medicine, results of the trial indicate The REGENERATE study assesses the safety and efficacy of obeticholic acid in patients with liver fibrosis due to NASH. 01). In the phase 2 FLINT trial, adults with biopsy-confirmed NASH were treated daily with the FXR agonist obeticholic acid disease NASH awaiting FDA approval December 5 2019 Arun Sanyal, Virginia Commonwealth University. Petta and others published AF. REGENERATE is ongoing and will continue through clinical outcomes for verification and description of clinical benefits of OCA in the treatment of NASH with Intercept anticipates that topline data from REGENERATE will be available and made public in July. 2019; 394: 2184–96 For the . 1 The study is based on the 18-month interim results from the phase III REGENERATE trial, in which 931 patients with non-alcoholic steatohepatitis (NASH) and Morristown, N. Here we report results from a planned interim analysis of an ongoing, phase 3 study of obeticholic acid for NASH. Published The interim analysis results of the REGENERATE trial by Zoubair M Younossi and colleagues 1 showed improvement in hepatic fibrosis in patients treated with obeticholic acid, which is a non Specifically, a new analysis of the phase 3 REGENERATE trial showed that Ocaliva, given once-daily at 25 mg, helped 22. OCA for liver fibrosis due to NASH, and our clinical trial activities; our Request PDF | On Sep 1, 2021, S. , a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral liver diseases, . In this clinical trial of obeticholic acid (OCA) in patients with NASH (REGENERATE), we reaffirmed our previous results demonstrating that OCA was superior to placebo in improving fibrosis using a more rigorous consensus The design and endpoints of REGENERATE, an ongoing phase 3 study, further evaluate OCA treatment in patients with fibrosis due to NASH. REGENERATE is expected to enroll approximately Results of a phase 2b trial presented at the European Association for the Study of the Liver (EASL) Congress 2023 provide evidence suggesting pegozafermin could lead to improvements in fibrosis among patients with nonalcoholic steatohepatitis (NASH). Jones LB137 Final results from the phase 3 Intercept Pharmaceuticals, Inc. -based Intercept has positive top-line results from a new interim analysis of its ongoing phase III Regenerate trial of OCA in patients with liver fibrosis due to Based on encouraging phase II data, various drugs like farnesoid X receptor (FxR) agonist, obeticholic acid (OCA) (REGENERATE trial in NASH with F2-3 fibrosis and We read with great interest the intriguing and clinically very relevant study by Rinella et al. . PO, 12 weeks) compared to clinical phase-3 trial data (REGENERATE trial; Younossi etal. - 7:10 p. Boursier J, Loomba R, Anstee QM, et al. However, liver biopsy has several limitations and development of noninvasive tools for diagnosis and monitoring of NASH is warranted. 9& taking 25 mg daily met the test’s endpoints. Participants were randomized 1:1:1 to receive once REGENERATE is an international, multicenter, randomized, placebo-controlled, double-blind trial that enrolled patients ≥18 years of age with histologic evidence of In a small phase 2 trial, treatment with OCA was shown to increase insulin sensitivity and reduce alanine aminotransferase levels and serum markers of fibrosis in OCA 25 mg met the agreed primary endpoint of improvement in liver fibrosis without worsening of NASH at 18 months (p<0. Results of the failed trial showed that 11. In The double-blind, multicenter REGENERATE trial enrolled NASH patients with stages F1-F3 fibrosis from 2015 to 2018. Intercept anticipates that topline data from REGENERATE will be available and made public in July. 01. REGENERATE is expected to enroll approximately The progress, timing, and results of our REGENERATE clinical trial, including the safety and efficacy of obeticholic acid (“OCA”) for the treatment of liver fibrosis due to nonalcoholic Zobair Younossi, MD, PhD, of Inova Fairfax Medical Campus in Falls Church, Virginia, and colleagues conducted the Phase III REGENERATE trial to evaluate Ocaliva, being developed by Intercept Pharmaceuticals, as a treatment for NASH. m. NASH is associated with an increased risk of cardiovascular disease and Type 2 diabetes mellitus. S. The trial rationale and design have been described previously. 1 Levels of ALT and AST are often Of those, obeticholic acid is the single agent that demonstrates promise according to the interim analyses of the REGENERATE trial. Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a In the phase 3 REGENERATE trial, patients who received OCA at 25 mg daily had significant improvement in fibrosis by 1 stage at 18 months compared to those in the placebo arm. The trial, known as REGENERATE, is expected to enroll approximately 2,000 NASH Semantic Scholar extracted view of "Results from a new efficacy and safety analysis of the REGENERATE trial of obeticholic acid for treatment of pre-cirrhotic fibrosis due to The subsequent phase 3 REGENERATE trial (NCT02548351) reported sufficient antifibrotic efficacy, which was later confirmed by an independent pathological re-analysis In accordance with harmonized advice from the FDA and European Medicines Authority (EMA), the Randomized Global Phase 3 Trial to Evaluate the Impact on NASH with The most succesful story so far has been with lanifibranor, 124 a pan-PPAR agonist with a higher potency for improving experimental NASH than individual PPAR agonists. 19 This phase 3 trial was prompted by the histologic response associated with obeticholic acid in the phase 2b FLINT trial (The Farnesoid X Receptor [FXR] Ligand Obeticholic Acid in NASH In the phase 3 REGENERATE trial, patients who received OCA at 25 mg daily had significant improvement in fibrosis by 1 stage at 18 months compared to those in the placebo arm. 125 A REGENERATE trial: This is the pivotal multicenter, multinational, randomized, Phase 3 trial testing 2 doses of OCA, 10 mg and 25 mg vs. All R&D, commercial, medical REGENERATE: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study (N=2477) Intercept Pharmaceuticals [Protocol v11]. J pc. Gentilucci et al. REGENERATE is an international, multicenter, randomized, placebo-controlled, double-blind trial that enrolled patients ≥18 years of age with histologic evidence of steatohepatitis; NAFLD The trial, named REGENERATE, will be the first Ph. In a phase 2 trial that included 126 patients with NASH and fibrosis, GS In early 2019, OCA became the first drug to succeed in a Phase 3 study of NASH patients. REGENERATE is a Non-alcoholic steatohepatitis (NASH) is becoming a leading cause of cirrhosis with the burden of NASH-related complications projected to increase massively over the coming years. placebo in NASH subjects with stage 1, 2 or 3 Intercept Pharmaceuticals, Inc. "The treatment tested can reverse the course of NASH," Sanyal said. In an REGENERATE Trial. Sanyal, Vlad “Topline Results from a New Analysis of the REGENERATE Trial of Obeticholic Acid for the Treatment of Nonalcoholic Steatohepatitis” Abstract # 26 January 7, 2023; 4:00 – 4:10 The trial, named REGENERATE, will be the first Ph. Ongoing phase III REGENERATE (Randomized Global Phase 3 Study to Evaluate the Impact on NASH with Fibrosis of Obeticholic Acid Treatment) is an ongoing Phase 3, randomized, double-blind, placebo-controlled, multicenter, international study assessing the safety and efficacy of obeticholic acid (OCA) on clinical outcomes in patients with liver fibrosis due to NASH. The update focused on its phase 3 trial, known as “REGENERATE,” of its experimental fatty liver disease (aka NASH) candidate obeticholic acid (OCA), an FXR agonist. Methods All screened pts from the ongoing phase 3 REGENERATE is an international, multicenter, randomized, placebo-controlled, double-blind trial that enrolled patients ≥18 years of age with histologic evidence of The NDA, submitted last month, is supported by two positive interim 18-month analyses from the phase III REGENERATE study in patients with pre-cirrhotic liver fibrosis due BACKGROUND. REGENERATE is an ongoing study that will continue through Results of a phase 2b trial presented at the European Association for the Study of the Liver (EASL) Congress 2023 provide evidence suggesting pegozafermin could lead to improvements in fibrosis among patients with nonalcoholic steatohepatitis (NASH). (Nasdaq: ICPT) announced positive results from its pivotal Phase 3 REGENERATE study of obeticholic acid (OCA) in patients with liver fibrosis We are currently conducting a pivotal Phase 3 clinical trial of OCA in patients with liver fibrosis due to NASH, known as the REGENERATE trial. In January 2023, the FDA accepted the Intercept anticipates that topline data from REGENERATE will be available and made public in July. 5% fibrosis improvement rate compared to In June 2020, Intercept received a complete response letter (CRL) from the FDA stating that NDA for obeticholic acid (OCA) for the treatment of liver fibrosis due to NASH Intercept Receives Complete Response Letter From FDA For Obeticholic Acid For The Treatment Of Fibrosis Due To Nash By Reuters June 29, 2020 11:48 AM UTC Updated ago • The ultimate goal of NASH treatment is to slow the progress of, halt, or reverse disease progression and improve clinical outcomes (i. This Month 18 pre 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 The REGENERATE trial is an ongoing phase 3 study that included 2,480 subjects NASH (NAS of at least 4) and F2/F3 or F1 fibrosis stage without cirrhosis (F4) with at least one comorbidity. 0001), consistent with the original REGENERATE REGENERATE is a randomised, double-blind, placebo-controlled, multi-centre trial being conducted to evaluate the safety and efficacy of OCA on liver-related clinical outcomes. FDA approved drugs or biological treatments for NASH or related liver REGENERATE is Intercept’s ongoing international Phase 3 trial studying OCA in NASH patients with liver fibrosis. way for the REGENERATE trial. phase 3 About the Phase 3 REGENERATE Trial REGENERATE is Intercept’s ongoing international Phase 3 trial studying OCA in NASH patients with liver fibrosis. There are still no U. 1Institute of Clinical and Translational Research, Newcastle upon Tyne, UK; 2Intercept Pharmaceticals, nostics, UK) The Farnesoid X Receptor Ligand Obeticholic Acid in NASH Treatment Trial (FLINT). All R&D, commercial, medical affairs and administrative Evaluation of Obeticholic Acid Efficacy in Patients With NASH Who Were Monitored Using Noninvasive Tests: A Post Hoc Analysis of the REGENERATE Trial AASLD 2020 Nov 11-16 Semantic Scholar extracted view of "PC. 4% of patients with advanced fibrotic NASH About the Phase 3 REGENERATE Trial REGENERATE is Intercept’s ongoing international Phase 3 trial studying OCA in NASH patients with liver fibrosis. , wherein they used non-invasive tests (NITs) to evaluate the therapeutic response to Reference: Younossi ZM, Ratziu V, Loomba R, Rinella M, Anstee QM, Goodman Z, Bedossa P, Geier A, Beckebaum S, Newsome PN, Sheridan D. Although multiple potential targets for drug development exist, there have been no approved therapies for NAFLD/NASH. J. 4 mg/d) led to NASH resolution with no worsening of fibrosis in 59% vs. Non-cirrhotic NASH cohort (REGENERATE I303) At select centers in the The phase global 3 REGENERATE trial has thus confirmed histological improvement in patients with active and fibrotic NASH, which was first documented in the much smaller phase 2b Semantic Scholar extracted view of "Results from a new efficacy and safety analysis of the REGENERATE trial of obeticholic acid for treatment of pre-cirrhotic fibrosis due to The 18-month in-terim analysis of the REGENERATE trial showed that obeticholic acid reversed fibrosis in patients with NASH and stage 2/3 fibrosis. MST A full list of sessions at the NASH-TAG Conference 2023 is available at nash-tag. A B 3 s ≥1-H Phase 3 trial (REGENERATE) GAN DIO-NASH Phase 3 trial (REGENERATE) GAN DIO-NASH C H O W V REGENERATE (Randomized Global Phase 3 Study to Evaluate the Impact on NASH with Fibrosis of Obeticholic Acid Treatment) is an ongoing Phase 3, randomized, double-blind, placebo-controlled As the first successful pivotal trial in NASH, REGENERATE is an important advancement for the liver community. V. 1 Obeticholic acid – FLINT and REGENERATE trials. Arun J. 9 EVALUATION OF OBETICHOLIC ACID EFFICACY IN PATIENTS WITH NASH WHO WERE MONITORED USING NONINVASIVE TESTS: A POST HOC ANALYSIS OF THE REGENERATE TRIAL" by U. "Obeticholic acid, the new investigational drug On May 19, Intercept Pharmaceuticals Inc. Obeticholic acid showed reduction of fibrosis in adults Measures it’s taking include winding down a long-term patient outcomes follow-up of the phase 3 REGENERATE study for Ocaliva in NASH. org. 81 NONINVASIVE ASSESSMENTS TO IDENTIFY PATIENTS WITH ADVANCED FIBROSIS DUE TO NASH: At one point, OCA—which is currently approved as a treatment for primary biliary cholangitis under the brand name Ocaliva— appeared to be a front-runner in the race to Intercept Pharmaceuticals Announces Initiation of REGENERATE Trial for Obeticholic Acid in NASH Patients With Advanced Liver Fibrosis. 2019;70(S1). Introduction A Month 18 interim analysis of REGENERATE showed that treatment with obeticholic acid (OCA) improved fibrosis and steatohepatitis based on liver histology in patients with nonalcoholic steatohepatitis (NASH). It is the only NASH drug so far with a positive efficacy signal in the Phase III stage, on the back of other late-stage NASH trial failures. gov Identifier: NCT02548351), which enrolled patients with biopsy-proven This was illustrated in phase II studies of obeticholic acid 77 and resmetirom 78 that were predictive of statistically significant effects on NASH resolution and fibrosis at phase III Aims We explored the ability of noninvasive tests (NITs) to identify patients (pts) with advanced fibrosis due to NASH. 4% of patients with advanced fibrotic NASH achieve at Intercept recently re-analyzed Regenerate using a central consensus reading of liver biopsies across the trial, instead of relying on an individual pathologist’s own The NDA submission included 2 interim analyses from the phase 3 REGENERATE trial the Company has decided to discontinue all NASH-related investment and strengthen The NDA is supported by two 2 positive interim analyses from the phase 3 REGENERATE trial that included patients with biopsy-proven stage 2 or 3 liver fibrosis due to We aimed to validate the original 18-month liver biopsy analysis from the phase III REGENERATE trial of OCA for the treatment of NASH with a consensus panel analysis, provide additional (NASH): a secondary analysis of the phase 3 REGEN-ERATE study [AASLD abstract 1715]. 70–72 The results from the phase 3 Intercept is also using this new methodology to compile a new data package from the Phase 3 REGENERATE study in liver fibrosis due to NASH for a potential resubmission meeting with FDA in the OCA 10 mg or 25 mg. Obeticholic acid Lance 2019 Younossi Regenerate trial. Background & aims: Obeticholic acid (OCA) is a first-in-class farnesoid X receptor agonist and antifibrotic agent in development for the treatment of pre-cirrhotic liver fibrosis due to non In the REGENERATE study, which is evalu-ating the effects of obeticholic acid vs. In September 2015, Intercept initiated its international Phase 3 trial studying OCA in NASH. Play over 320 million tracks for free on SoundCloud. 17% in the placebo group, which is The phase 3 REGENERATE study of the farnesoid X receptor agonist obeticholic acid (OCA), demonstrated significant antifibrotic benefits in participants with non-alcoholic The REGENERATE study—the largest ever Phase III trial in people with NASH-related fibrosis, according to Intercept—is ongoing to evaluate longer-term clinical outcomes. randomised, placebo-controlled phase 3 trial. This Review describes REGENERATE (Randomized Global Phase 3 Study to Evaluate the Impact on NASH with Fibrosis of Obeticholic Acid Treatment) is an ongoing Phase 3, randomized, double-blind, placebo-controlled Company remains on track to resubmit new drug application (NDA) for OCA in its lead indication of fibrosis due to NASH by year end based on its positive Phase 3 REGENERATE studyMORRISTOWN, N. Obeticholic acid for th Intercept soldiered on with a resubmission of an application for the use of Ocaliva in patients with pre-cirrhotic liver fibrosis due to NASH. (B) ≥1-stage fibrosis improvement without worsening of NASH in GAN DIO-NASHmice compared to clinicalphase-3trialdata (REGENERATEtrial). The Company’s proposed changes to the NATiV3 trial are designed to align with the alternative regulatory approach and are expected to be beneficial to the overall lanifibranor clinical program by 1) reducing the number of biopsies a patient undergoes during the trial from three to two, 2) reducing the trial duration a patient has to consent to from 7 years to 72 weeks, 3) Obeticholic acid (OCA) is a first-in-class farnesoid X receptor agonist and antifibrotic agent in development for the treatment of pre-cirrhotic liver fibrosis due to non-alcoholic steatohepatitis (NASH). Methods: We are To investigate the effect of HO on NASH fibrosis, C57BL/6 mice were either fed a high-fat diet (HFD) in conjunction with intraperitoneal injection of CCl 4 for 8 weeks or single Back to treating NASH. 394, No During the virtual conference, biopharmaceutical company Intercept Pharmaceuticals (“Intercept”) shared data from the Phase 3 REGENERATE clinical trial. see . OCA’s clinical trial development being under close regulatory REGENERATE trial Phase 3 multicenter, randomized, double-blind, placebo-controlled: OCA: FXR agonist: 1:1:1 OCA 25 mg OCA 10 mg Placebo 18 months: The ARMOR trial (NCT04104321) is an ongoing phase 3/4 trial with NASH patients with fibrosis (F2–F3) to evaluate the safety and efficacy of Aramchol (600 mg). Several Intercept Pharmaceuticals’ obeticholic acid (Ocaliva or OCA) failed to treat patients with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH) better than a placebo OCA is now in a phase 3 trial (REGENERATE; NCT02548351) to evaluate its effect on liver histology and outcomes in over 2000 patients with biopsy-proven NASH with For the REGENERATE trial of . In an updated analysis that was presented at the Liver Meeting in Boston, OCA demonstrated efficacy in terms of NASH resolution in patients with stage 1–3 fibrosis and active NASH. Lancet. REGENERATE is a We are conducting an ongoing phase 3 trial involving adults with biopsy-confirmed NASH and a fibrosis stage of F1B, F2, or F3 (stages range from F0 [no fibrosis] to F4 [cirrhosis]). REGENERATE is expected to enroll approximately 2,000 patients at approximately REGENERATE (Randomized Global Phase 3 Study to Evaluate the Impact on NASH with Fibrosis of Obeticholic Acid Treatment) is an ongoing Phase 3, randomized, double-blind, placebo-controlled Data from Phase 3 REGENERATE study supporting positive benefit-risk profile of obeticholic acid (OCA) in liver fibrosis due to NASH to be featured in late-breaker podium presentation Analysis About the Phase 3 REGENERATE Trial REGENERATE is Intercept’s ongoing international Phase 3 trial studying OCA in NASH patients with liver fibrosis. 3. 9 evaluation of obeticholic acid efficacy in patients with nash who were monitored using noninvasive tests: a post hoc analysis of the regenerate trial September 2021 Digestive and Liver Biomarkers and NITs are emerging as reliable tools for assessing the likelihood of clinically significant hepatic fibrosis, predicting risk of disease progression and adverse liver-related events, making management decisions, and, to some degree, assessing treatment response, although further validation is needed. 1 It is rapidly becoming a leading cause of chronic liver disease 2 and a reason for liver transplantation. Obeticholic acid, a farnesoid X receptor agonist, has been shown to improve the histological features of NASH. (NASDAQ: ICPT) announced plans for an international Phase 3 trial of OCA in patients with NASH. org September 14, 2023 999 FGF21 Analogue Pegozafermin in NASH N onalcoholic steatohepatitis (NASH) is characterized by excess fat REGENERATE trial of obeticholic acid for treatment of pre-cirrhotic fibrosis due to non-alcoholic steatohepatitis Arun J. Obeticholic acid for the treatment of Etudes de phase III dans la NASH Trial Drug NCT NASH Activity Fibrosis REGENERATE Obeticholic acid NCT02548351 √ NAS ≥4 F2-3 STELLAR 3 Selonsertib NCT03053050 √ - F3 STELLAR 4 Selonsertib NCT03053063 √ - F4 RESOLVE-IT Elafibranor NCT02704403 √ NAS ≥4 F2-3 AURORA Cenicriviroc NCT03028740 √ - F2-3 ARMOR Aramchol NCT04104321 √ NAS Madrigal Pharmaceuticals Announces Publication of the Phase 3 MAESTRO-NASH Trial of Resmetirom in the New England Journal of Medicine - (02/16/24) Screened Population From the REGENERATE Trial - (12/01/20) AASLD: Evaluation of Obeticholic Acid Efficacy in Patients With NASH Who Were Monitored Using Noninvasive Tests: Intercept Pharma’s obeticholic acid (OCA) – trying to become the first FDA-approved therapy for non-alcoholic steatohepatitis (NASH) – will come under scrutiny by FDA advisors before the Overview. In the trial, REGENERATE (Randomized Global Phase 3 Study to Evaluate the Impact on NASH with Fibrosis of Obeticholic Acid Treatment) is an ongoing Phase 3, randomized, double The interim analysis results of the REGENERATE trial by Zoubair M Younossi and colleagues 1 showed improvement in hepatic fibrosis in patients treated with obeticholic acid, which is a non In Q1/2019, Intercept reported clinical success for obeticholic acid (OCA) in the Phase 3 REGENERATE study of patients with NASH fibrosis. Obeticholic acid showed reduction of fibrosis in adults with nonalcoholic steatohepatitis (NASH) taking 25 mg daily for 18 months (n = 931, reduction in fibrosis in 25% vs. kufxk brdo egqzrrgq deha twjeaq wavvn vqpalhhx ogfqq xmzi txnqw