Hepion's NASH drug meets main goal of improving liver function in mid-stage trial

Hepion Pharmaceuticals Inc said yesterday its treatment met the main goal of improving liver function in patients with a type of fatty liver disease in a mid-stage study trial, sending its shares 45 per cent higher in premarket trading. The drug, rencofilstat, was also found to be safe in the 61-patient trial, with the 225 mg dose showing the greatest benefit to liver function and multiple biomarkers associated with NASH (non-alcoholic steatohepatitis), the company said. Hepion was conducting trials on three doses, with the 225 mg dose being the highest.

Hepion Pharmaceuticals (Nasdaq: HEPA) is a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”), fibrotic diseases, hepatocellular carcinoma (“HCC”), and other chronic diseases. The Company’s lead drug candidate, rencofilstat, is a potent inhibitor of cyclophilins, which are involved in many disease processes.

Rencofilstat has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental disease models and is currently in Phase 2 clinical development for the treatment of NASH. In November 2021, the U.S. Food and Drug Administration (“FDA”) granted Fast Track designation for rencofilstat for the treatment of NASH. That was followed in June 2022 by the FDA’s granting of Orphan Drug designation to rencofilstat for the treatment of HCC.