EDISON, NJ / ACCESSWIRE / December 10, 2019 / 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”), today announced the successful advancement to the next higher dose in its ongoing clinical trial of CRV431, a Phase 1 multiple ascending dose (“MAD”) study.

The open-label MAD study was initiated in the third quarter of 2019 to assess safety, tolerability and pharmacokinetics of CRV431 in healthy volunteers. The study is designed to examine doses of 75 mg, 150 mg, 225 mg and 300 mg, with the potential to assess higher doses, where CRV431 is administered orally, once daily for 28 days.

Data are reviewed by a Clinical Trial Management team between each successive increase in dosing levels. The team’s review of the 75 mg cohort data showed this dosing level to be safe and well tolerated, which authorized escalation to the next dosing level of 150 mg daily for 28 days. In addition to studying the safety, tolerability, and exposure after dosing of CRV431, the maximum tolerated dose in humans will be determined.

“As we proceed to the next dosing level, we will continue to monitor blood concentrations of CRV431, and all markers of safety,” said Dr. Stephen Harrison, Hepion’s Consultant Medical Director. “The data generated from this trial is expected to guide further development of CRV431 for the treatment of NASH, with plans to initiate Phase 2 clinical studies in the first half of 2020.”

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 other types of hepatitis. 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 cyclophilins, 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.