Hepion Pharmaceuticals Inc. (NASDAQ: HEPA) stock declined by 1.9% at last close whereas the HEPA stock-price gains by 5.81% in the pre-market trading session. Hepion Pharmaceuticals is a clinical-stage pharmaceutical business focused on AI-driven therapeutic medication discovery for non-alcoholic steatohepatitis and liver disorders.
HEPA stock’ Recent Past Development
Hepion Pharmaceuticals has released new effectiveness results from its AMBITION Phase 2a clinical study. A total of 43 NASH patients were included in AMBITION, a multicenter, randomised, placebo-controlled, single-blind Phase 2a study. The study’s goal was to look at once-daily oral administration of CRV431 at dosages of 75 mg (n=12) and 225 mg (n=17) as soft gelatin capsules for 28 days in assumed F2 and F3 NASH patients, accompanied by a 14-day safety monitoring period.
All of the AMBITION NASH trial’s main outcomes were fulfilled, as previously stated. Hepion just published new data on biomarkers, alanine aminotransferase, and N-terminal type III collagen pro-peptide (“Pro-C3”), in addition, they also released improved pharmacologic and bioinformatics studies, all of which suggest that CRV431 is efficacious in curing NASH patients.
Stephen Harrison, MD, will present the entire AMBITION study at the next AASLD “The Liver Meeting” in early November 2021.
Hepion’s Chief Medical Officer, Todd Hobbs MD commented,
The decrease in Pro-C3 shown in the AMBITION study brings them in line with NASH results reported by other firms with late-stage NASH treatment candidates. However, significant decreases in Pro-C3 with CRV431 occurred in about 4 weeks, as opposed to several months with other agents.
Hepion’s Senior VP, Clinical Pharmacology & Analytics, Patrick Mayo, stated,
They can conclude two things from these biomarker discoveries. First, as demonstrated by the Pro-C3 alterations on day 42, CRV431 has a long-lasting impact. These findings can be explained by CRV431’s extended terminal half-life, in fact, circulating blood concentrations of CRV431 are still detectable at day 42, despite the fact that drug administration stopped on day 28. Second, they were prepared to implement their machine learning and proprietary AI-POWR to work, after the most recent data they have deduced from their AMBITION study. They’ve been able to build models that can predict who will react to CRV431 proactively.