Hepion Pharmaceuticals Inc (HEPA)

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Hepion shares fall after CRV431 mid-stage NASH study results

Jul. 13, 2021 8:32 AM ETHepion Pharmaceuticals, Inc. (HEPA)

By: Aakash Babu, SA News Editor

Hepion Pharmaceuticals (NASDAQ:HEPA) shares fall more than 7% premarket despite announcing that its CRV431 treatment met all primary endpoints in a mid-stage trial of patients with non-alcoholic steatohepatitis ("NASH").

The study was a Phase 2a randomized, multi-center, placebo controlled, single-blind trial designed to investigate once daily oral administration of CRV431 at doses of 75 mg and 225 mg administered as soft gelatin capsules to presumed F2 and F3 NASH subjects for 28 days.

CRV431 at both study doses was well tolerated, and there were no serious adverse events (“SAEs”), and the few adverse events (“AEs”) observed were mostly mild and unrelated to study drug, the company said.

Results showed reductions in liver transaminases, which indicate dose-related improvements in a key NASH biomarker.

Early indications of efficacy in the form of alanine aminotransferase (ALT) reductions were observed with both CRV431 dosing cohorts.

The percent ALT change from baseline to Day 28 numerically demonstrated a CRV431 versus placebo dose-response, the company said.