Hepion Pharmaceuticals (NASDAQ:HEPA) completed recruitment for its Phase 2a AMBITION clinical trial, with all non-alcoholic steatohepatitis (NASH) patients in the 225 mg CRV431 dosing cohort now enrolled.
After completion of 28 days dosing with either CRV431 or placebo, study subjects will be monitored for an additional 14-day period, during which time Hepion will continue to collect data, focusing on CRV431’s safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy.
“It is certainly rewarding for the Hepion clinical team to see the conclusion of enrollment for the AMBITION trial,” Dr. Todd Hobbs, M.D., Hepion’s newly appointed CMO, said in a statement.
The Phase 2a AMBITION study is a single-blinded, placebo controlled trial designed to assess safety, tolerability, pharmacokinetics, and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431. Study drug or placebo are administered orally, with 18 subjects in each dosing cohort, once daily for 28 days.
Hepion will also examine several biomarkers, including collagens, matrix metalloproteinases, lipidomics, genomics, liver transaminases, Pro-C3, ELF score, gene-gene, gene-protein network analysis and Fibroscan to determine early assessments of efficacy of CRV431 in the treatment of NASH.
In addition, Hepion will use AI-POWR, its proprietary bioinformatics and AI platform that allows for precision medicine, to optimize the understanding the activity of CRV431 in NASH, which will also guide further development of CRV431 in subsequent clinical studies.