Renocofilstat’s Positive Outcomes Reinforce Antifibrotic Action
Hepion Pharmaceuticals, a clinical stage biopharmaceutical company focusing on AI-assisted therapeutic drug development, recently disclosed promising topline results from the Phase 2 ALTITUDE-NASH clinical trial. The trial showcased an improved physiological liver function and a reduction in key NASH biomarkers including ALT, ProC3, PIIINP, and ELF, bolstering rencofilstat’s direct antifibrotic mode of action.
ALTITUDE-NASH Trial Meets Primary Endpoint
In the ALTITUDE-NASH trial, rencofilstat improved liver function in subjects with stage 3 or greater fibrosis, according to the AGILE 3+ criteria, successfully meeting its primary endpoint. Besides, the trial saw a reduction in liver injury biomarkers and multiple fibrosis-associated biomarkers, reinforcing rencofilstat’s antifibrotic mode of action. The findings elevate confidence in fibrosis reductions for Hepion’s ongoing Phase 2b ASCEND-NASH paired biopsy trial.
Hepion Pharmaceuticals: Four Measures of Liver Impairment Show Significant Improvement
An FDA-issued Investigational Device Exemption (IDE) study using the HepQuant SHUNT Test recorded significant improvements in four measures of liver impairment compared to baseline after a four-month rencofilstat treatment. The four measures included the HepQuant DSI™ score, SHUNT, HepQuant HR™, and RISK ACE. The rencofilstat 225 mg treatment resulted in statistically significant decreases in all four measures, with 61% of subjects witnessing a DSI improvement of >2.0 points.
Secondary Endpoints Achieved: Enhanced Fibrosis and Injury-Associated Biomarkers
Fibrosis-related biomarkers including ProC3, PIIINP, TIMP1, and hyaluronic acid, along with liver injury markers ALT and AST, improved after four months of rencofilstat treatment. Rencofilstat 225 mg led to the highest improvements in NASH biomarkers, especially in high-risk subjects with elevated baseline ProC3 levels.
Safety and Tolerability of Renocofilstat
The trial’s safety endpoints were met with no serious adverse events attributed to rencofilstat. Out of 70 subjects enrolled, 67 completed all study procedures, showcasing rencofilstat’s high tolerability. The trial recorded no hepatic decompensation events or deaths, further strengthening its safety profile.
ALTITUDE-NASH Trial: A Precursor to Larger, Longer Studies
The ALTITUDE-NASH trial served as a stepping stone for Hepion’s current 12-month Phase 2b ASCEND-NASH liver biopsy-based trial. As Dr. Stephen Harrison, Chair of Hepion’s Scientific Advisory Board, expressed, the successful outcomes of this trial foster confidence in positive outcomes for the larger, longer Phase 2b ASCEND-NASH biopsy trial.
Emphasizing Personalized Treatment
The study also provided valuable data to enrich Hepion’s AI-POWR™ platform. Patrick Mayo, PhD, Hepion’s Senior Vice President, Clinical Pharmacology & Analytics, highlighted that the platform will enhance future studies by predicting rencofilstat responders, de-risking future studies, including potential Phase 3 trials, and providing clinicians with the ability to tailor rencofilstat treatment for patients who are expected to respond. This personalized approach might shape Hepion’s future commercial strategy.
Hepion Pharmaceuticals continues to strengthen its position in NASH treatment research, pushing the boundaries of AI-assisted therapeutic drug development, and anticipating further progress in upcoming trials.
Hepion Pharmaceuticals Market Response:
Shares of Hepion Pharmaceuticals (NASDAQ: HEPA) are surging 90% through afternoon trading on Monday, May 22, 2023. Over the past three months, Hepion has seen average daily volume of 18,320 shares. However, volume of 12.1 million shares or dollar volume of around $201 million, has already exchanged hands through afternoon trading. As of this writing, shares of HEPA are up over 176% year-to-date.
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