HEPA Hepion Pharmaceuticals Inc

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”), fibrotic diseases, hepatocellular carcinoma (“HCC”), and other chronic diseases, today announced the publication of a new research study in mice, where Hepion’s lead drug candidate, rencofilstat, prevented the growth of liver tumors that occurred as a result of chronic infection with the human hepatitis C virus (“HCV”).

The study was published in the peer-reviewed, open access scientific journal, Viruses, and was conducted by Drs. Winston Stauffer, Philippe Gallay, and colleagues at The Scripps Research Institute (La Jolla, California). Mice were infected with HCV, which caused the development of small liver nodules at around 12 weeks post-infection that progressed to very large tumors by 24 weeks post-infection. Daily rencofilstat treatment was initiated at week 0 or later time points:

• When initiated at week 0, rencofilstat treatment completely prevented HCC development measured at week 30 likely because the drug also blocked HCV infection and therefore eliminated a key driver of HCC development;
• When initiated at week 12, when tumors were in a small nodular stage, rencofilstat treatment similarly resulted in no visible nodules or tumors at week 30, suggesting that rencofilstat was able to completely regress small cancerous nodules; and
• When initiated at week 16, when livers contained many small-to-medium-sized nodules and tumors, rencofilstat treatment resulted in significantly decreased numbers and sizes of tumors (“tumor burden”) measured at week 30, which also indicated preventative or regressive anti-tumor activity.

To investigate whether some of rencofilstat’s anti-HCC effects occurred independent of its anti-HCV activity, rencofilstat was compared to the anti-HCV agents sofosbuvir and velpatasvir, which belong to the recently developed direct-acting class of HCV drugs representing billions of dollars in annual sales.

Sofosbuvir, velpatasvir and rencofilstat treatments initiated at week 16 all eliminated HCV infection. However, only rencofilstat decreased tumors when measured at week 30. Sofosbuvir and velpatasvir-treated mice developed the same large tumor burden as mice that received no drug treatment, whereas the tumor burden of rencofilstat-treated mice was 80% lower.

“These results highlight one of rencofilstat’s greatest strengths, which is the ability to exert pleiotropic effects that can be harnessed to treat multiple diseases,” said Dr. Daren Ure, Hepion’s Chief Scientific Officer. “This contrasts with highly selective drugs that target single mechanisms, such as the currently available anti-HCV drugs that do not effectively treat liver cancer arising from HCV infection. We believe that rencofilstat is the ideal treatment for this kind of cancer as it stops viral replication and suppresses cancer through separate and complementary pathways.”

Dr. Robert Foster, Hepion’s CEO, added “The antiviral, anti-cancer, and antifibrotic activities of rencofilstat address many of the most deadly and prevalent diseases affecting people today. Not only could rencofilstat have an enormous impact on human health, but the investment growth opportunities associated with treating these high-need, global-scale diseases are equally large.”

Hepion recently announced a new mechanism by which rencofilstat exerts anti-cancer activity in liver cancer and the drug’s anti-cancer activity in numerous cell lines representing 86% of cancer types.

The Viruses journal article, entitled “The Cyclophilin Inhibitor Rencofilstat Decreases HCV-Induced Carcinoma Independently of Its Antiviral Activity”, can be accessed here.

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 Artificial Intelligence deep machine learning (“AI/ML”) platform designed to better understand disease processes and identify patients that are rencofilstat responders. This AI/ML has the potential to shorten development timelines and increase the observable differences between placebo and treatment groups. In addition, Hepion’s AI/ML can be used to drive its ongoing NASH and HCC clinical development programs and identify other potential therapeutic indications for cyclophilin inhibition with rencofilstat.

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 KilmerHepion Pharmaceuticals Investor RelationsDirect: (646) 274-3580skilmer@hepionpharma.com