Early completion of enrollment in phase II ‘ALTITUDE-NASH’ liver function trial of rencofilstat

The trial is being conducted in collaboration with HepQuant, LLC and Summit Clinical Research at 20 sites within Summit’s Integrated Research Organization.

ALTITUDE-NASH is a Phase II, randomized, multi-center, open-label study designed to evaluate the safety and efficacy of lon hepatic function and numerous NASH biomarkers after four months of dosing. Subjects enrolled in the trial were classified as NASH stage F3 based on either historical biopsy or by using the AGILE 3+ criteria, defined by a screening Fibroscan score alongside common clinical and laboratory parameters. Subjects are randomized to receive a once daily, oral dose of 75, 150, or 225 mg rencofilstat soft gelatin capsules (20 subjects in each dosing cohort) over a period of four months. The HepQuant ‘SHUNT’ test, a measure of hepatic function, will be performed at baseline, and changes in the Disease Severity Index (“DSI”) score relative to baseline measurements will be determined at days 60 and 120. Other NASH biomarkers will be collected throughout the study duration.

Greg Everson, MD, FACP, HepQuant’s Founder and Chief Scientific Researcher, said, “The enrollment rate of this NASH clinical trial has exceeded all expectations; 60 patients in 12 weeks is all but unprecedented. Notably, enrollment was accelerated by Hepion’s decision to propose improvement in liver function – measured using HepQuant’s technology – as an endpoint, eliminating liver biopsy as criteria for entry and for monitoring treatment effects.

The vast majority of NASH investigators and sponsors are lamenting the costly problems of slow enrollment and high dropout rates, mainly related to dependency on liver biopsy. Hepion is suggesting an alternative, where demonstration of functional improvement, along with improvement in other non-invasive tests, could enable more rational study endpoints and facilitate the conduct of NASH trials.”.

Todd Hobbs, MD, Hepion’s Chief Medical Officer, added, “Having initiated dosing in the larger and longer Phase IIb ‘ASCEND-NASH’ trial, Hepion’s priority is to use the ALTITUDE-NASH trial to understand the impact of three different doses of rencofilstat on NASH subjects, based on hepatic function and biomarkers. Modelling these results over the course of four months should allow us to better predict the outcome of the one-year, biopsy-confirmed ASCEND-NASH trial.”