Hepion Pharmaceuticals

Hepion Pharmaceuticals (Nasdaq: HEPA) is a biopharmaceutical company focused on the development of pleiotropic drug therapy for treatment of chronic liver disease. This therapeutic approach targets fibrosis and hepatocellular carcinoma (HCC) associated with non-alcoholic steatohepatitis (NASH), viral hepatitis, and other liver diseases. Our cyclophilin inhibitor, CRV431, is being developed to offer benefits to address these multiple complex pathologies. CRV431 targets multiple biochemical pathways involved in the progression of liver disease. Preclinical studies with CRV431 in NASH models demonstrated consistent reductions in liver inflammation, fibrosis, and cancerous tumors. Additionally, CRV431 shows antiviral activity towards hepatitis B, C, and D viruses which also trigger liver disease. The multiple mechanisms of action of CRV431 equate to many therapeutic opportunities for alleviating the life-threatening risks of liver disease. CRV431 has been tested in Phase 1 human clinical trials. Our drug candidate demonstrated good safety and tolerability in oral doses ranging from 75 mg to 525 mg. As expected, the pharmacokinetics of CRV431 showed increasing maximal blood concentrations as doses increased. Systemic blood exposures demonstrated good linearity up to 375 mg, which we anticipate will be more than sufficient for efficacy, based on our preclinical testing. The half-life of CRV431 was long and supports once daily oral administration. Data from our preclinical program and our phase 1 clinical trial support the further advancement of CRV431 in liver disease.