Hepion Pharmaceuticals Inc. (NASDAQ: HEPA) stock declined by 5.23% at last close whereas the HEPA stock price soars by 3.07% in the pre market trading session. CRV431, Hepion Pharmaceuticals’ lead drug candidate, is a powerful inhibitor of cyclophilins, which play a role in a variety of diseases. CRV431 is currently in clinical trials for the prevention of NASH, and it has the ability to play a significant part in the treatment of liver disease as a whole, from the onset of symptoms to end-stage disease.
Significant recent development
Hepion Pharmaceuticals reported on May 6, 2021, that enrollment for its Phase 2a ‘AMBITION’ clinical trial is now done, with all NASH patients in the 225 mg CRV431 dosing cohort enrolled.
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The Phase 2a ‘AMBITION’ trial is a single-blinded, placebo-controlled trial designed to evaluate the stability, tolerability, pharmacokinetics, and biomarker analyses of 75 and 225 mg CRV431. The study medication or placebo is given orally once daily for 28 days (n=18 participants in each dosing cohort). Hepion will also look at biomarkers like collagens, matrix metalloproteinases, lipidomics, genomics, liver transaminases, Pro-C3, ELF score, gene-gene, gene-protein network review, and Fibroscan to see if CRV431 is effective in treating NASH early on. Hepion will be using AI-POWRTM, the proprietary Bioinformatics and AI software that enables precision medicine, to refine the understanding of CRV431 operation in NASH, which will also direct CRV431 growth in the future clinical studies.
Dr. Robert Foster, Hepion’s CEO stated:
The COVID-19 pandemic, exacerbated by inclement weather at some of HEPA’s clinical trial sites in Texas, which resulted in power failures, has made recruiting participants for the second and final dosing cohort of our Phase 2a NASH trial challenging in recent months. HEPA was able to conquer these obstacles, and they are proud to announce that AMBITION is now completely registered. Post 28 days of dosing with CRV431 or placebo, research participants will be tracked for another 14 days, during which time we will continue to collect data – concentrating on CRV431’s efficacy, tolerability, pharmacokinetics, and biomarker tests for early.