Benzinga | Nov 18, 2020 07:37AM EST

Hepion Pharmaceuticals Announces Data Safety Monitoring Board Recommends Continuation Of Phase 2a 'AMBITION' Clinical Trial For Treatment Of Advanced NASH



- Interim DSMB review at the midpoint of the first dose cohort affirmed no safety or tolerability concerns with 75 mg of CRV431 in NASH patients -

- DSMB recommended the AMBITION study continue with 225 mg CRV431 dose cohort -

- Clinically significant reductions observed in the liver safety parameters ALT and AST -

EDISON, NJ / ACCESSWIRE / November 18, 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 an independent Data Safety Monitoring Board ("DSMB") has approved the continuation of the company's Phase 2a 'AMBITION' clinical trial to the next dose level cohort, after evaluating the safety and tolerability of the 75 mg CRV431 dose cohort in NASH patients. The study will now enroll NASH patients in the 225 mg dose cohort.

The AMBITION trial is the first placebo-controlled study of CRV431 in NASH patients with evidence of moderate-to-severe fibrosis. In this study, CRV431 is administered orally, once-daily for 28 days. The primary objectives of the trial are to assess safety and tolerability of CRV431, as well as to delineate pharmacokinetics. The secondary outcome measure of the trial is to evaluate decreases in non-invasive antifibrotic markers from baseline to the end of study. The study is being conducted at 10 sites in the U.S.

Dr. Stephen Harrison MD, Hepion's Consultant Medical Director, commented, "The DSMB review of the first CRV431 dose cohort in the Phase 2a AMBITION trial affirmed there were no safety or tolerability concerns. Moreover, when focusing on parameters of liver chemistry safety labs, reductions in ALT and AST were observed at Day 28. These data are very encouraging for the continued development of CRV431 as an oral, once-daily antifibrotic treatment for NASH patients."

"We are pleased with the DSMB's positive recommendation and look forward to continuing our AMBITION trial in NASH patients with moderate-to-severe fibrosis," commented Dr. Robert Foster PharmD, PhD, Hepion's CEO. "There are currently no approved treatments for NASH, which affects approximately 17 million people in the U.S. and may lead to cirrhosis, cancer, and death. This positive recommendation is an important advance for our company and in the quest to develop an orally active, once-daily, direct-acting antifibrotic to treat advanced NASH patients."