1/7/2023 0 Comments Stage plot pro trialToday, Hepion reports additional data on biomarkers, alanine aminotransferase (“ALT”) and N-terminal type III collagen pro-peptide (“Pro-C3”), as well as advanced pharmacologic and bioinformatic analyses that indicate CRV431 efficacy in treating NASH patients. The trial was designed to investigate once daily oral administration of CRV431 at doses of 75 mg (n=12) and 225 mg (n=17) administered as soft gelatin capsules to presumed F2 and F3 NASH subjects for 28 days, followed by a 14-day observation period for safety.Īs previously reported, all primary endpoints of the AMBITION NASH trial (safety, tolerability and pharmacokinetics) were met. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”) and liver disease, today announced additional efficacy data from its Phase 2a AMBITION clinical trial.ĪMBITION, a multicenter, randomized, placebo controlled, single-blind Phase 2a trial, enrolled 43 NASH patients. Anti-fibrotic gene expression signature revealed in bioinformatic analysesĮDISON, N.J., Sept.Hepion’s proprietary AI-POWR™ and machine learning accurately predict CRV431 responders.PK-PD models successfully predict early reductions in Pro-C3 and ALT. Pro-C3 and ALT reductions point to anti-inflammatory and antifibrotic effects of CRV431.
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