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About ALTITUDE-NASH
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
About
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
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
skilmer@hepionpharma.com
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