Hepion Pharma gets FDA IND clearance for CRV431 in liver cancer (HCC), enabling direct Phase 2 start

Hepion Pharmaceuticals, Inc.

FDA accepted IND for CRV431 for hepatocellular carcinoma; allows Phase 2 trial to begin without Phase 1.
CRV431 is a liver-targeting cyclophilin inhibitor; also being studied for NASH with Phase 2b ASCEND-NASH expected in 2022.
Positive Phase 2a AMBITION NASH data previously reported; CRV431 well-tolerated with all primary endpoints met.
Company highlights CRV431's oral dosing and potential anti-tumor mechanisms including immune modulation.
Expansion into HCC complements existing NASH pipeline with a single once-daily oral agent.

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