OA-235i / Oasis Pharma - LARVOL DELTA

Coagulation protease-activated receptor-2 (PAR2) promotes dyslipidemia, obesity and MASLD through repression of the hepatic pioneer factor HNF4α. (PubMed, JHEP Rep) - "These data provide support that targeting hepatic PAR2 may potentially provide broad liver and cardiometabolic benefits to patients with MASLD and MASH."

Journal • Diabetes • Dyslipidemia • Fibrosis • Genetic Disorders • Hematological Disorders • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • Thrombosis

Safety Study of OA-235i in Subjects With Nonalcoholic Steatohepatitis (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Oasis Pharmaceuticals, LLC | Recruiting ➔ Completed | Phase classification: P1a/1b ➔ P1 | Trial completion date: Apr 2024 ➔ Jul 2024 | Trial primary completion date: Feb 2024 ➔ Jul 2024

Phase classification • Trial completion • Trial completion date • Trial primary completion date • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

FIRST-IN-HUMAN PHASE 1 STUDY OF THE SAFETY AND PHARMACODYNAMIC EFFECTS OF OA-235I, A PAR2 PEPDUCIN, IN ADULTS WITH METABOLIC-ASSOCIATED STEATOTIC LIVER DISEASE (MASLD) AND STEATOHEPATITIS (MASH) (AASLD 2024) - "Resmetirom, a thyroid hormone-derived metabolic drug, recently received conditional FDA approval based on its safety and efficacy on surrogate endpoints of MASH resolution and fibrosis regression. OA-235i, a PAR2 inhibitor, is safe and well-tolerated. Early efficacy signals on metabolic parameters justify further investigation of PAR2 as a therapeutic target for treatment of MASH."

Clinical • P1 data • PK/PD data • Diabetes • Fibrosis • Genetic Disorders • Hepatology • Immunology • Inflammation • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

Safety Study of OA-235i in Subjects With Nonalcoholic Steatohepatitis (clinicaltrials.gov) - P1a/1b | N=23 | Recruiting | Sponsor: Oasis Pharmaceuticals, LLC

New P1 trial • Hepatology • Non-alcoholic Steatohepatitis