EDISON, N.J., Sept. 14, 2022 — Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”), hepatocellular carcinoma (“HCC”), and other chronic liver diseases, today announced that its research collaborators from London’s Institute of Hepatology will present new findings on the Company’s cyclophilin inhibitor, rencofilstat, in an awarded oral presentation at the 2022 joint meeting of the International Society for Biomedical Research on Alcoholism (ISBRA) and European Society for Biomedical Research on Alcoholism (ESBRA), taking place September 17-20, 2022 in Cracow, Poland.
Alcohol-associated liver disease (“ALD”) is a global health burden with a lack of effective therapies. Previous studies have demonstrated that cyclophilins participate in various stages of liver disease, including steatosis, fibrosis, inflammation, cell injury and HCC.
The study to be presented evaluated the effects of rencofilstat in human tissue-derived experimental models of ALD, and on fibrosis in primary hepatic stellate cell (“HSC”) cultures. In addition to reducing alpha-smooth muscle actin and improving collagen fiber alignment in HSCs, rencofilstat profoundly reduced the expression and secretion of pro-fibrogenic markers and restored a balanced cytokine profile in patient-matched precision cut liver slices exposed to hepatotoxic insults.
“These data confirm the role of cyclophilins in liver fibrosis – including HSC activation, collagen deposition and orientation – while also revealing, for the first time, rencofilstat’s therapeutic potential to reduce ALD-induced fibrosis,” said Dr. Robert Foster, PharmD, PhD, Hepion’s CEO.
Oral Presentation Details
| Abstract title: | Cyclophilin inhibitor Rencofilstat as a potential therapy for Alcohol-associated Liver Disease |
| Authors: | Elena Palma1,2, Una Rastovic1,2, Sara Campinoti1,2, Nicola Harris1,2, Omolola Ajayi1,2, Bruna Almeida1,2, Tsin Shue Koay1,2, Sandra Phillips1,2, Karoline Lackner3, Daren Ure4, Melissa Preziosi5, Rosa Miquel5, Yoh Zen5, Andreas Prachalias5, Krishna Menon5, Nigel Heaton5, Luca Urbani1,2, Shilpa Chokshi1,2 |
| Presenter: | Una Rastovic |
| Session: | 34 – Free Oral Communications 5 |
| Date: | Tuesday, September 20, 2022 |
| Time: | 11.45 am CET |
1The Roger Williams Institute of Hepatology, Foundation for Liver Research; 2King’s College London, Faculty of Life Sciences and Medicine; 3Institute of Pathology, Medical University of Graz; 4Hepion Pharmaceuticals; 5Institute of Liver Studies, King’s College London
Forward-Looking Statements
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.
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.
For further information, please contact:
Stephen Kilmer
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580
skilmer@hepionpharma.com
