– HepQuant Evaluation Offers Sensitive Measurement of Hepatic Function and Correlation with Clinical Outcomes –
– Dedicated Phase 2b Trial Supports Overarching NASH Program for Rencofilstat –
– Four-Month, Three Arm Trial will Inform on Numerous NASH Functional Biomarkers –
EDISON, N.J., May 03, 2022 (GLOBE NEWSWIRE) — Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”), Hepatocellular Carcinoma (“HCC”), and other chronic liver diseases, today announced that it has entered into a clinical collaboration with HepQuant, a Denver-based, privately held company with novel, proprietary investigational technology for evaluating liver function and health in patients with chronic liver diseases. Hepion will incorporate the HepQuant ‘SHUNT’ test into a dedicated Phase 2b clinical trial in presumed NASH F3 subjects, initiating in Q3 of this year.
Hepion will evaluate three doses of rencofilstat (CRV431) in 60 presumed NASH F3 subjects using the HepQuant SHUNT test along with numerous NASH biomarkers collected over four months of once daily oral dosing. HepQuant’s SHUNT test may provide a sensitive measurement of hepatic function and is designed to provide detailed information on the role rencofilstat plays in improving the liver health in NASH subjects with advanced fibrosis.
This trial will supplement the Company’s larger 12-month Phase 2b NASH clinical trial in biopsy-proven F2/F3 NASH subjects (‘ASCEND-NASH’), which will begin in Q3 of this year; and will run concurrently with Hepion’s ongoing Phase 2a clinical trial for hepatocellular carcinoma (“HCC”).
“Challenges in conducting liver biopsies in NASH clinical programs are well recognized, so we are impressed with the SHUNT test’s potential to indicate changes in liver health over short periods of time, and even potentially replace the need for biopsy in NASH trials,” commented Todd Hobbs, MD, Hepion’s Chief Medical Officer. “The HepQuant SHUNT test will allow us to collect significant data on rencofilstat’s impact on hepatic function after a four-month dosing period, much longer than that of our Phase 2a AMBITION trial that was completed last year. We are looking forward to gaining added confidence in rencofilstat’s ability to improve fibrosis in NASH patients as we begin our larger Phase 2b biopsy trial in parallel.”
HepQuant’s CEO and Chief Medical Officer, Greg Everson, MD commented, “The noninvasive, blood-based HepQuant SHUNT test of liver function and physiology addresses the unmet need for an endpoint that directly quantifies liver health in liver therapeutic trials. In many ways, HepQuant SHUNT is to the liver as creatinine clearance is to the kidney – as HepQuant SHUNT worsens, the likelihood of clinical complications or clinical outcomes of liver disease increases. We have used the test in studies of HCV, HCC, NASH, PSC, cirrhosis; and in interventional trials in HCV, NASH, and HCC. Our research suggests that HepQuant SHUNT could be a useful tool for detecting early treatment effects, dose response, target engagement, and time of onset of action of drugs or treatments.”
Robert Foster, PharmD, PhD, Hepion’s CEO, commented, “Our mandate at Hepion is to provide answers to transformative questions as quickly as possible. We recognize that our Phase 2b ASCEND-NASH trial will take time to generate results, as we need to account for subject recruitment and subsequent dosing of rencofilstat for 12 months before the final study read-out. In the meantime, however, we believe HepQuant’s technology will enable us to determine the impact of rencofilstat on liver function in an expeditious manner, with accelerated clinical read-outs compared with the Phase 2b ASCEND-NASH study. As biopsy studies are a requirement of regulators, Hepion will conduct both the paired biopsy ASCEND-NASH trial and the HepQuant trial simultaneously; the latter providing important answers in a shorter timeframe.