Hepion Pharmaceuticals Inc (NASDAQ:HEPA) jumped around 25% on Tuesday after the company disclosed "positive" top line data from the low-dose cohort in its Phase 2a 'AMBITION' clinical trial of CRV431.
The Edison, New Jersey-based company reported two interim analyses were performed by a Data Safety Monitoring Board 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.
"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.
HEPA shares gathered 30 cents, or 14.4%, to $2.38.
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