- 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