EDISON, NJ, USA I July 29, 2019 I Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a biopharmaceutical company focused on the development of therapeutic drugs for the treatment of liver disease arising from non-alcoholic steatohepatitis (“NASH”) and chronic viral infection, today announced that the U.S. Food and Drug Administration (“FDA”) has reviewed its Investigational New Drug (“IND”) application for CRV431 for the treatment of NASH and has authorized that the Company proceed with its planned IND opening study. This IND for NASH is in addition to the Company’s current open IND for hepatitis B virus (“HBV”).

“We are delighted that the FDA has cleared our IND and we are excited to commence clinical trials of CRV431 for NASH, an increasingly prevalent disease for which there are currently no approved therapies,” commented Dr. Robert Foster, the Company’s CEO. “Based on the preclinical and clinical studies we’ve conducted, CRV431’s anti-fibrotic and anti-inflammatory properties demonstrate its significant potential as a novel therapy for NASH, and more broadly, for liver disease.”

“This is an important milestone that allows us to continue with CRV431’s clinical development for NASH in addition to HBV. We look forward to commencing our IND opening study this year, which will assess CRV431 in patients with varying degrees of hepatic impairment.”

Hepion’s planned IND opening study, entitled “An Open-Label Single-Dose Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of CRV431,” will enroll 24 patients consisting of eight with mild, eight with moderate, and eight with severe hepatic impairment, based on established Child-Pugh scores. Up to an additional 24 healthy subjects will serve as the control group. The objective of the IND opening study and proposed clinical development program is to characterize the safety, tolerability and pharmacokinetics of CRV431 monotherapy in patients with liver disease to establish dose ranges for patients with differing degrees of NASH.  

About Hepion Pharmaceuticals

Hepion Pharmaceuticals is a clinical stage biopharmaceutical company focused on the development of targeted therapies for liver disease arising from non-alcoholic steatohepatitis (NASH) and chronic hepatitis virus infection (HBV, HCV, HDV). The Company’s lead drug candidate, CRV431, reduces liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH. Preclinical studies also have demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms. These diverse therapeutic activities result from CRV431’s potent inhibition of cyclophilin enzymes, which are involved in many disease processes. Currently in clinical phase development, CRV431 shows potential to play an important role in the overall treatment of liver disease – from triggering events through to end-stage disease.

SOURCE: Hepion Pharmaceuticals