HEPA - FDA clears Hepion Pharma's CRV431 application for liver cancer

Hepion Pharmaceuticals (NASDAQ:HEPA) announces that the FDA has accepted its investigational new drug (IND) application for CRV431, a liver-targeting, novel cyclophilin inhibitor, for the treatment of hepatocellular carcinoma (HCC). Shares up 1.7% premarket at $1.23. On July 29, 2019, Hepion received FDA authorization to initiate the study of CRV431 for the treatment of NASH. To date, Hepion has completed Phase 1 studies in healthy volunteers and, more recently, announced positive data from its Phase 2a ‘AMBITION’ trial. A larger Phase 2b NASH study of over 300 subjects with paired liver biopsies, called ‘ASCEND-NASH’, is expected to be initiated in 2022. ASCEND-NASH will evaluate CRV431’s effects on the histologic endpoints of liver steatosis and fibrosis over 12 months dosing.

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FDA clears Hepion Pharma's CRV431 application for liver cancer