Hepion Pharmaceuticals, Inc. announced additional efficacy data for rencofilstat, its lead drug candidate. Additional rencofilstat efficacy data from Hepion?s ?ALTITUDE-NASH? clinical trial was presented earlier this afternoon by Dr. Mayo in a late-breaker poster presentation at the Liver Meeting® 2023, hosted by the American Association for the Study of Liver Diseases (?AASLD?).

Dr. Mayo?s presentation indicated that 17 weeks of rencofilstat treatment was associated with significant reduction in liver stiffness (FibroScan®) in MASH subjects with advanced F3, an outcome suggesting reduction in hepatic fibro-inflammation. Ongoing hepatic fibro-inflammation leads to progressive accumulation of collagen or fibrosis, increasing liver stiffness, and functional deterioration. Determination of liver stiffness often utilizes an ultrasound-based imaging technique called vibration-controlled transient elastography (?VCTE?) of which FibroScan® is the most common platform.

Physicians rely on liver stiffness measurements as a diagnostic tool to help determine whether liver health is worsening or improving, as the measurements correlate well with the extent of fibrosis in liver biopsies and are predictive of the course of disease. The predictive power of liver stiffness measurements on the course of disease is further enhanced when taken together with blood-based markers of liver disease. Liver stiffness measurements are expressed in kilopascals (kPa), and Fibroscan® scores higher than 12 kPa usually represent advanced forms of fibrosis (F3 or F4 in biopsies).

Reduction in liver stiffness by rencofilstat likely indicates reduction in fibroinflammation, and reduction in risk for subsequent clinical outcome. Patients who participated in the study and received a once-daily oral dose of 225 mg rencofilstat experienced an average decline of 6.02 kPa (LSMean) from their baseline measurement. When expressed as a percentage, rencofilstat treatment decreased liver stiffness by a mean of 28.8% (95% CI, -44.3%, -13.4%) from baseline over 17 weeks (p=0.001).

This change from baseline was among the highest reductions ever measured in F2-F3 MASH studies. The ALTITUDE-NASH study was a multi-center, open label study in F3 MASH subjects identified by historical biopsy or having AGILE 3+ screening score of 0.53 or higher. Subjects were randomized to one of three rencofilstat treatment groups receiving either 75 mg, 150 mg, or 225 mg soft gelatin capsules once daily for a period of 17 weeks.

The objective of this study was to collect a wide range of information on rencofilstat dosing levels, safety, and efficacy to optimize designs of subsequent studies.