Benzinga | Dec 29, 2020 07:32AM EST

Hepion Pharmaceuticals Data Safety Monitoring Board Recommends Continuation With Final Dose Cohort In Phase 2a 'AMBITION' Clinical Trial For Treatment Of Advanced NASH

- DSMB Review After Completion of the First Dose Cohort Affirmed No Safety or Tolerability Concerns with CRV431 in NASH Patients -

- DSMB Recommended the AMBITION Study Continue with Final Dosing Cohort -

- Final Cohort Expected to be Completed in Early 2021 -

EDISON, NJ / ACCESSWIRE / December 29, 2020 / Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA, &quot, , Hepion&quot, , ))))), 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 that an independent Data Safety Monitoring Board ("DSMB") has approved the continuation of the Company's Phase 2a 'AMBITION' clinical trial.

Two interim analyses were performed by a DSMB to evaluate the safety and tolerability of the 75 mg CRV431 dose cohort in NASH patients. The first analysis occurred half-way through the first dosing cohort and this, the second analysis, occurred at the completion of the first dosing cohort.

Hepion's lead novel drug candidate, CRV431, is a pan-cyclophilin inhibitor that inhibits multiple forms of cyclophilins. Cyclophilins, of which there are 17 known isoforms in humans, play a central role in protein folding and contribute to numerous biological effects including inflammation and fibrosis, to name a few. NASH, which is a severe form of non-alcoholic fatty liver disease affects approximately 17 million people in the U.S. and is a leading cause of liver transplantation. NASH may also lead to cirrhosis, liver cancer and death. Formation of liver fibrosis has been linked to mortality in NASH. To date, there are no approved drugs to treat NASH.

The AMBITION trial is the first placebo-controlled study of CRV431 in NASH patients with evidence of moderate-to-severe fibrosis. In this study, which is being conducted at 10 U.S. sites, CRV431 is administered orally, once-daily for 28 days. The primary objectives of the AMBITION trial are to assess safety and tolerability of CRV431, as well as to delineate pharmacokinetics. The secondary outcome measure of this Phase 2a trial is to evaluate decreases in non-invasive antifibrotic markers from baseline to the end of the study. Data from the AMBITION trial will be used alongside Hepion's proprietary AI-POWRTM to guide and enrich future study design.

"This is the second successful review by the DSMB of our AMBITION trial in NASH patients with moderate-to-severe fibrosis," commented Dr. Robert Foster, Hepion's CEO. "Now that we have completed dosing in our 75 mg cohort, we are enrolling our final dosing cohort of 225 mg. Dosing of all patients is expected to be completed in Q1-2021 with final data read-out for both dosing cohorts expected thereafter. The release of our top line preliminary data from our 75 mg dosing group is imminent. Despite the challenges of conducting a clinical trial during the COVID-19 pandemic, we continue to make good progress."