HEPA - Hepion Pharmaceuticals gets FDA fast track designation for CRV431 to treat liver disease

The U.S. Food and Drug Administration granted fast track designation to Hepion Pharmaceuticals (HEPA) lead drug candidate CRV431 to treat non-alcoholic steatohepatitis (NASH), a type of liver disease. “CRV431 has been investigated in healthy subjects during our Phase 1 program, and more recently in subjects with presumed F2 and F3 NASH in our Phase 2a AMBITION study,” said Todd Hobbs, Hepion’s chief medical officer. Hobbs noted that CRV431 has been well-tolerated and has shown signals of efficacy in NASH in this early Phase 2 study. The company is looking forward to initiating a larger phase 2b NASH study, called ‘ASCEND-NASH’, in biopsy confirmed F2 and F3 NASH patients in the coming months. HEPA +4.92% premarket to $1.28

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Hepion Pharmaceuticals gets FDA fast track designation for CRV431 to treat liver disease