EDISON, N.J., Nov. 10, 2023 — 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”), fibrotic diseases, hepatocellular carcinoma (“HCC”), and other chronic diseases, today announced that it expects to release additional efficacy data from the Phase 2 ALTITUDE-NASH clinical trial of its lead drug, rencofilstat, after market close on Monday, November 13, 2023. The data release will follow a late-breaker poster presentation by Hepion’s Senior Vice President, Clinical Pharmacology, Patrick Mayo, PhD, at the Liver Meeting® 2023, to be hosted by the American Association for the Study of Liver Diseases (AASLD) November 10-14, 2023, in Boston, MA.
Hepion is pleased to invite all interested parties to participate in a conference call at 4:30 p.m. ET on November 13, 2023, during which the additional ALTITUDE-NASH efficacy data will be discussed. To participate in this conference call, please dial (800) 715-9871 (U.S.) or (646) 307-1963 (international), conference ID 8619177, approximately 10 minutes prior to the start time. The call will also be broadcast live and archived on the Company’s website at www.hepionpharma.com under “Events” in the Investors section.
ALTITUDE-NASH, a Phase 2, randomized, multi-center, open-label study, enrolled 70 subjects 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. The study was designed to evaluate the safety and efficacy of rencofilstat on hepatic function and numerous NASH biomarkers after four months of dosing. Subjects were randomized to receive a once daily, oral dose of 75, 150, or 225 mg rencofilstat soft gelatin capsules (20 subjects in each dosing cohort). The HepQuant ‘SHUNT’ test, a measure of hepatic function, was performed at baseline, and changes in the Disease Severity Index (“DSI”) score relative to baseline measurements were determined at days 60 and 120. Other NASH biomarkers were collected throughout the study duration.
In May 2023, Hepion announced that ALTITUDE-NASH had achieved its primary and secondary endpoints, including improvement in liver function and multiple NASH biomarkers.
About Hepion Pharmaceuticals
The Company’s lead drug candidate, rencofilstat, is a potent inhibitor of cyclophilins, which are involved in many disease processes. Rencofilstat has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental disease models and is currently in Phase 2 clinical development for the treatment of NASH. In November 2021, the U.S. Food and Drug Administration (“FDA”) granted Fast Track designation for rencofilstat for the treatment of NASH. That was followed in June 2022 by the FDA’s granting of Orphan Drug designation to rencofilstat for the treatment of HCC.
Hepion has created a proprietary Artificial Intelligence deep machine learning (“AI/ML”) platform designed to better understand disease processes and identify patients that are rencofilstat responders. This AI/ML has the potential to shorten development timelines and increase the observable differences between placebo and treatment groups. In addition, Hepion’s AI/ML can be used to drive its ongoing NASH and HCC clinical development programs and identify other potential therapeutic indications for cyclophilin inhibition with rencofilstat.
For further information, please contact:
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580