Benzinga | Nov 10, 2020 09:09AM EST

Hepion Pharmaceuticals Completes First Cohort Enrollment In Phase 2a 'AMBITION' Clinical Trial

EDISON, NJ / ACCESSWIRE / November 10, 2020 / Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on the development of therapeutic drugs for the treatment of liver disease arising from non-alcoholic steatohepatitis ("NASH"), today announced that it has enrolled the last patient in the 75 mg CRV431 cohort of its Phase 2a 'AMBITION' clinical trial.

"We are pleased to have reached this important milestone in our ongoing CRV431 development program for the treatment of NASH," said Dr. Robert Foster, Hepion's CEO. "We are continuing to compile the data - which will focus on CRV431's safety, tolerability, pharmacokinetics, and biomarker analyses for early assessments of efficacy - and anticipate having follow-up from this 75 mg dosing cohort by the end of 2020. In addition, the data will be used in big data analytics via our proprietary AI-POWR(tm) platform."

"NASH and fibrosis represent a significant and growing burden on the health care system," commented Dr. Stephen Harrison, Hepion's Consultant Medical Director. "Developing an oral anti-fibrotic therapy for this condition that is safe, well-tolerated and efficacious is critical. I am excited to see this first 28-day treatment cohort enrolled and look forward to assessing how the non-invasive tests for fibrosis perform in this cohort enriched for more advanced disease."

The open-label Phase 2a 'AMBITION' study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg CRV431, administered orally to F2 and F3 NASH patients (n=18), once daily for 28 days. Hepion will also examine several biomarkers including collagen, matrix metalloproteinases, lipidomics, genomics, liver transaminases, Pro-C3, ELF score, gene-gene, gene-protein network analysis, and Fibroscan in a multivariate multi-omics analysis to determine early assessments of efficacy of CRV431 in the treatment of NASH. In addition, Hepion will use AI-POWR(tm), its in-house proprietary big data analytics 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.