EDISON, N.J., Nov. 02, 2022 — Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of fibrotic diseases, including non-alcoholic steatohepatitis (“NASH”), hepatocellular carcinoma (“HCC”), and other chronic diseases, today announced that two poster presentations highlighting its lead drug candidate, rencofilstat, will be given at the Liver Meeting® 2022, to be hosted by the American Association for the Study of Liver Diseases (AASLD) November 4-8, 2022, in Washington, DC.
Details of the poster presentations are as follows:
Title: The Effect of Rencofilstat on the Multi-Omics of Biomarker Assessed F2/F3 NASH Subjects
Authors: Mayo, P; Hobbs, T; Zhao, C; Foster, E; Ure, D; Trepanier D; Foster, R
Presenter: Patrick Mayo, PhD
Time: 13:00 – 14:00 ET
Title: Cyclophilin B knockout significantly limits the development of liver fibrosis in a diet and chemical-induced mouse model of NAFLD/NASH
Authors: Stauffer, W; Ure, D; Foster, R; Gallay, P
Presenter: Winston Stauffer, PhD
Time: 13:00 – 14:00 ET
“Data from the first of these two poster presentations serve to demonstrate the value of machine learning,” commented Robert Foster, PharmD, PhD, CEO of Hepion. “Using multi-omics, our pharmacology and analytics team was able to show that rencofilstat works on the several key pathways involved in NASH and could augment the effects of other potential NASH drugs. Key driver analysis suggests potential antifibrotic effects in lung, kidney, and heart fibrosis. Additionally, AI-POWR™ allowed us to accurately identify which rencofilstat subjects in our Phase 2a ‘AMBITION’ clinical trial for NASH would show reductions in Pro-C3, a biomarker of collagen formation and fibrosis. This information was used to enhance our ongoing Phase 2b ‘ASCEND-NASH’ trial designed to demonstrate the magnitude of rencofilstat’s antifibrotic effects over a 12-month-period and will allow us to better design our Phase 3 program and ultimately also help guide our commercialization strategy in future.”
Dr. Foster continued, “The second presentation, highlighting the findings of a study conducted by Dr. Philippe Gallay’s research group at The Scripps Research Institute demonstrated that mice lacking cyclophilin B are specifically protected from the development of liver fibrosis, which further validates the mechanism of action of rencofilstat.”
A copy of the presentation materials will be accessible on the Company’s website at www.hepionpharma.com under “Publications” in the Pipeline section.
About Hepion Pharmaceuticals
The Company’s lead drug candidate, rencofilstat, is a potent inhibitor of cyclophilins, which are involved in many disease processes. Rencofilstat is currently in clinical-phase development for the treatment of NASH, with the potential to play an important role in the overall treatment of liver disease – from triggering events through to end-stage disease. Rencofilstat has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH, and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms, in nonclinical studies. In November 2021, the U.S. Food and Drug Administration (“FDA”) granted Fast Track designation for rencofilstat for the treatment of NASH. That was followed in June 2022 by the FDA’s granting of Orphan Drug designation to rencofilstat for the treatment of HCC.
Hepion has created a proprietary AI platform, called AI-POWR™, which stands for Artificial Intelligence – Precision Medicine; Omics (including genomics, proteomics, metabolomics, transcriptomics, and lipidomics); World database access; and Response and clinical outcomes. Hepion intends to use AI-POWR™ to help identify which NASH patients will best respond to rencofilstat, potentially shortening development timelines and increasing the delta between placebo and treatment groups. In addition to using AI-POWR™ to drive its ongoing NASH clinical development program, Hepion intends to use the platform to identify additional potential indications for rencofilstat to expand the company’s footprint in the cyclophilin inhibition therapeutic space.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated,” and “intend,” among others. These forward-looking statements are based on Hepion Pharmaceuticals’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals’ Form 10-K for the year ended December 31, 2021, and other periodic reports filed with the Securities and Exchange Commission.
For further information, please contact:
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580