Hepion Pharmaceuticals Inc. (HEPA) stock prices were up by 3.61% shortly after market trading commenced on September 13th, 2021. This brought the price per share up to USD$1.72 early on in the trading day.
HEPA Stock’s AMBITION Trial
September 13th, 2021 saw HEPA stock announce additional efficacy data from its Phase 2a AMBITION clinical trial. The study is a multicenter, randomized, placebo-controlled, single=blind Phase 2a trial. A total of 43 patients have been enrolled. The study was designed to evaluate the company’s CRV431 treatment. The treatment will be administered orally once a day at doses of 75 mg (n=12) and 225 mg (n=17).
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Details of the Clinical Study
The treatment will be administered as soft gelatin capsules to presumed F2 and F3 NASH subjects for a period of 28 days. This will be followed by a 14-day observation period intended to evaluate post-treatment safety. According to previous reports, all of the primary endpoints of the AMBITION NASH trial have been met. This includes safety, tolerability, and pharmacokinetics endpoints.
Scope of HEPA Stock’s Results
The detailed analyses of the AMBITION trial data were conducted using HEPA stock’s proprietary AI-POWR platform. The results provided additional evidence of CRV-431’s efficacy in the treatment of NASH. The pharmacokinetic-pharmacodynamic analyses generated robust models. These models help predict whether individual patients would show reductions in ALT and Pro-C3 based on CRV431 exposure, baseline ALT, Pro-C3, and other demographic and clinical measurements. Analyses of full-genome, RNA sequencing data from the patients revealed the treatment to produce changes in gene expression. These changes were consistent with anti-fibrotic effects.
CRV431-induced changes in gene expression are labeled as a collagen-related gene regulatory network. The changes included six key collagen isoforms, as well as many other structural and enzymatic constituents of the fibrotic matrix. The analyses proved to be similar to the PK-PD models for both ALT and Pro-C3. Accordingly, supervised machine learning analyses categorized patients as responders or non responders on the basis of their transcriptome responses to CRV431 treatment.
Future Outlook for HEPA Stock
The first half of fiscal 2021 has been promising for HEPA stock, consolidated by the success of efficacy data from the AMBITION trial. The company is keen to leverage its resources to ensure the accelerated development and commercialization of its flagship treatment. Current and potential investors are confident that management will be able to usher in consistent and organic increases in shareholder value over the long term.