– Preclinical studies demonstrate rencofilstat may protect against NASH/NAFLD, shift the liver transcriptome and lipidome toward NASH resolution –
– Cyclophilin B inhibition confirmed as an important target for treatment of NAFLD/NASH –
EDISON, N.J., June 15, 2023 — Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on artificial Intelligence (“AI”)-assisted therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”), fibrotic diseases, hepatocellular carcinoma (“HCC”), and other chronic diseases, announced that two abstracts have been accepted for poster presentations at the European Association for the Study of the Liver (EASL) International Liver Congress™ 2023 taking place June 21 – 24, 2023 in Vienna, Austria and digitally.
The first poster, to be presented by The Scripps Research Institute’s Winston Stauffer, PhD, demonstrates the role of cyclophilin B in the development of NAFLD and NASH in preclinical models, confirming rencofilstat’s mechanism of action as a cyclophilin inhibitor can offer protection against the development of these diseases.
The second poster, to be presented by Hepion’s Chief Scientific Officer, Daren Ure, PhD, demonstrates that rencofilstat positively changes gene expression networks and lipid profiles in preclinical models toward resolution of NASH. The changes in gene expression observed in the studies overlapped with the effects of peroxisome proliferator-activated receptors (PPARs) and farnesoid X receptor (FXR) agonists – therapeutics used to treat chronic cholestatic and metabolic liver diseases.
Details of the accepted abstracts for poster presentations are as follows:
| Abstract Number and Identifier: | 1893; WED-420 |
| Abstract Title: | Mice lacking Cyclophilin B, but not Cyclophilin A, are significantly protected from the development of major features of NAFLD/NASH in a diet and chemical-induced model |
| Authors: | Winston Stauffer1, Daren Ure2, Robert Foster2, Philippe Gallay1 |
| Presenter: | Dr. Winston Stauffer |
| Session: | Poster – NAFLD: Experimental and pathophysiology |
| Date: | June 21, 2023 |
| Time: | 9:00am – 6:00pm |
| Abstract Number and Identifier: | 2552; WED-455 |
| Abstract Title: | Cyclophilin inhibition with rencofilstat shifts the liver transcriptome and lipidome in preclinical models toward resolution of nonalcoholic steatohepatitis |
| Authors: | Daren Ure2, Winston Stauffer1, Bhavesh Variya2, Lacey Haddon2, Patrick Mayo2, Philippe Gallay1, Robert Foster2 |
| Presenter: | Dr. Daren Ure |
| Session: | Poster – NAFLD: Experimental and pathophysiology |
| Date: | June 21, 2023 |
| Time: | 9:00am – 6:00pm |
1 The Scripps Research, United States, 2Hepion Pharmaceuticals/Research, Canada/United States
About Hepion Pharmaceuticals
The Company’s lead drug candidate, rencofilstat, is a potent inhibitor of cyclophilins, which are involved in many disease processes. Rencofilstat has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental disease models and is currently in Phase 2 clinical development for the treatment of NASH. 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 observable differences 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.
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, 2022, and other periodic reports filed with the Securities and Exchange Commission.
For further information, please contact:
Stephen Kilmer
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580
skilmer@hepionpharma.com
