Hepion Pharmaceuticals (NASDAQ: HEPA) shares are rallying after the company reported data from its low dose cohort in the Company’s Phase 2a ‘AMBITION’ clinical trial of CRV431 for the treatment of advanced non-alcoholic steatohepatitis (NASH).
Hepion’s share price is 44.23% higher premarket on Wednesday at $3, following Tuesday’s close at $2.08.
The Phase 2a study continues with the higher dose of 225 mg CRV431, with NASH patient dosing expected to be completed in the first quarter of 2021, Hepion said.
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The AMBITION trial is a placebo-controlled study of CRV431 in NASH patients with evidence of moderate-to-severe fibrosis.
In the study, which Hepion are conducting at 10 U.S. sites, 75 mg CRV431 (low dose) was administered orally, once daily for 28 days, while a second dosing cohort of 225 mg CRV431 (high dose) is ongoing. The company expects final results from both dosing cohorts after the high dose group has completed active dosing, followed by a 14-day observation period.
The trial’s primary endpoints are to assess the safety and tolerability of CRV431 and delineate pharmacokinetics. The secondary endpoint is to evaluate decreases in antifibrotic markers.
Hepion said the results from the low dose group showed that CRV431 was generally safe and well-tolerated.
“Although the primary focus of this Phase 2a study was to examine the safety and tolerability of CRV431 in NASH patients, we were hoping to see early signs of potential efficacy and are pleased with the results thus far. We will continue to monitor liver safety lab tests in our higher dose group and will also look at a panel of serum fibrosis biomarkers,” commented Dr Robert Foster, Hepion’s CEO.
