Hepion Pharmaceuticals (NASDAQ:HEPA) expects to release topline results from the Phase 2 ALTITUDE-NASH clinical trial with its rencofilstat drug candidate before the market opens on Monday, May 22, 2023.
The company also plans to hold a conference call at 8:30 am ET to discuss the ALTITUDE-NASH topline results.
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 mg, 150 mg, or 225 mg rencofilstat soft gelatin capsules, with 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 score relative to baseline measurements were determined at days 60 and 120. Other NASH biomarkers were collected throughout the study duration.