FOR IMMEDIATE RELEASE [
Covington, KY] August 13, 2020
– CTI Clinical Trial and Consulting Services (CTI), a global, privately held, full-service contract research organization, and Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a biopharmaceutical company focusing on the development of therapeutic drugs for the treatment of liver disease arising from non-alcoholic steatohepatitis (“NASH”), announce that CRV431 was administered to the first NASH patient. CTI, recently named number one CRO in the world for quality
, specializes in clinical trials with the unique challenges associated with hepatic populations, from mild to moderate liver disease to end stage acute and chronic liver disease.
The open-label phase 2a study, called the ‘AMBITION’ trial, is designed to assess safety, tolerability, and pharmacokinetics of CRV43. Hepion previously announced that CRV431 successfully progressed through a phase 1 program, where the safety, tolerability and pharmacokinetics of CRV431 were evaluated in healthy subjects.
“We are very pleased to partner with Hepion on this novel study in NASH, which affects millions of people around the world,” according to Timothy J. Schroeder, CTI Chief Executive Officer. “This milestone is a testament to the Hepion and CTI teams, who are working tirelessly to progress this important study.”
Dr. Robert Foster, Hepion’s Chief Executive Officer stated, “We believe NASH is a very heterogenous disease with complex biochemical and pathological processes complicated, for example, by time and genetics. As such, treating NASH may be tantamount to hitting a moving target. We believe we can mitigate much of the usual risks associated with clinical trials, and NASH in particular, by utilizing cutting edge data tools allowing for precision medicine. We will be drawing upon our vast expertise in cyclophilin drug development, honed over decades of experience, to further the advancement of CRV431 in the clinic.”