Hepion Pharmaceuticals’ Phase 2 ‘ALTITUDE-NASH’ Trial Achieves Primary and Secondary Endpoints, Including Improvement in Liver Function and Multiple NASH Biomarkers
- Improvements in physiologic liver function and key NASH biomarkers including ALT, ProC3, PIIINP and ELF -
- Results reinforce rencofilstat’s direct antifibrotic mode of action; increases confidence for reductions in fibrosis in ongoing Phase 2b ‘ASCEND-NASH’ paired biopsy trial -
EDISON, N.J., May 22, 2023 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on artificial Intelligence (“AI”)-assisted therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”), fibrotic diseases, hepatocellular carcinoma (“HCC”), and other chronic diseases, today announced positive topline results from its recently completed Phase 2 ALTITUDE-NASH clinical trial.
ALTITUDE-NASH met its primary endpoint by demonstrating improved physiologic liver function and was well tolerated after four months of treatment in subjects with stage 3 or greater fibrosis based on the AGILE 3+ criteria. All additional secondary endpoints were also met, including reductions in the liver injury biomarkers, alanine and aspartate transaminases (“ALT” and “AST”); and multiple fibrosis-associated biomarkers, including ProC3 (procollagen 3 C-terminal peptide), PIIINP (procollagen 3 N-terminal peptide), TIMP1 (tissue inhibitor of metalloproteinase-1), hyaluronic acid, and enhanced liver fibrosis (“ELF”) scores (composite of PIIINP, TIMP1, and hyaluronic acid). These observations build on similar findings from a shorter Phase 2a trial and reinforce rencofilstat’s direct antifibrotic mode of action and increase the confidence for reductions in fibrosis in Hepion’s ongoing Phase 2b ASCEND-NASH paired biopsy trial.
“We are thrilled that the ALTITUDE-NASH trial met both its primary efficacy and safety endpoints, in particular with the 225 mg rencofilstat dose showing the greatest benefit to liver function and multiple NASH-associated biomarkers,” said Todd Hobbs, MD, Hepion’s Chief Medical Officer. “This trial was designed to inform us on how well rencofilstat improves hepatic function in those with significant impairment and risk for complications from their advanced NASH. Further, it provided an opportunity to evaluate data generated from different doses of rencofilstat. I am very pleased with the research team and the ALTITUDE-NASH sites that quickly recruited this study. Our improved understanding of which subjects best respond to rencofilstat can be immediately applied to increase the likelihood of success of our larger and longer ASCEND-NASH paired biopsy trial.”
Primary Endpoint: Four Measures of Liver Impairment Significantly Improved Compared to Baseline with Four Months Rencofilstat 225 mg Treatment
The HepQuant SHUNT Test was used in this study under an U.S. Food and Drug Administration (“FDA”)-issued Investigational Device Exemption (IDE). The SHUNT Test is a minimally invasive test that tracks changes in the degree of liver function impairment and was used to determine four key measures: HepQuant DSI™ (Disease Severity Index) score, which primarily reflects hepatocyte function; SHUNT, which reflects the impact of micro-architectural changes, such as fibrosis on blood flow through the liver; HepQuant HR™ (Hepatic Reserve); and RISK ACE, which reflects the annual risk of a patient developing an adverse clinical outcome (Table 1). Rencofilstat met the primary endpoint and lowered mean DSI score in all doses, with rencofilstat 225 mg treatment over 4 months resulting in statistically significant decreases in DSI (mean Δ = -1.62 units; p
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.