News & Events CTI and Hepion Pharmaceuticals Announces First NASH Patient Dosed with CRV431 in Phase 2 Clinical Trial

CTI and Hepion Pharmaceuticals Announces First NASH Patient Dosed with CRV431 in Phase 2 Clinical Trial

August 13, 2020

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.”

  

About CTI Clinical Trial and Consulting Services

CTI Clinical Trial and Consulting Services is a global, privately held, full-service contract research organization (CRO) who was recently ranked the #1 CRO in the world for Quality at the 2020 CRO Leadership Awards. The CRO delivers a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization. CTI’s focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine/gene therapy, immunology, transplantation, nephrology, hematology/oncology, neurology, infectious diseases, hepatology, cardiopulmonary, and pediatric populations. CTI also offers a fully integrated multi-specialty clinical research site that conducts phase I-IV trials. CTI has a passion for helping life-changing therapies succeed in chronically and critically ill patient populations. With clinical trial experience across 6 continents, CTI partners with research sites, patients, and sponsors to fulfill unmet medical needs. CTI is headquartered in the Greater Cincinnati, OH area, with operations across North America, Europe, Latin America, and Asia-Pacific. For more information visit www.ctifacts.com

  

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. 

  

For more information, please contact:

CTI Clinical Trial & Consulting
Allison Connaughton
aconnaughton@ctifacts.com

513-598-9290
 
Hepion Pharmaceuticals Investor Relations
Stephen Kilmer
skilmer@hepionpharma.com
646-274-3580

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