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”) and hepatocellular carcinoma (“HCC”), today announced the results of a nonclinical research study showing that its clinical phase drug candidate, rencofilstat (CRV431), synergistically decreased liver tumor growth and extended mouse survival when combined with an anti-PD1 antibody, an immune checkpoint inhibitor (“ICI”). The effects were observed in fatty livers, which may be associated with lower anti-PD1 efficacy in HCC, suggesting that rencofilstat may increase the treatment potential of anti-PD1 treatment in human liver cancer.

The study was conducted by Fibrofind Ltd (Newcastle, UK) in collaboration with Professor Derek Mann, Dean of Research, and Innovation at Newcastle University. In this study, mice were first fed a Western-type diet (high fat, cholesterol, and sugar) for three months to generate fatty livers, followed by surgical implantation of cancerous HCC cells (mouse hep53.4 cell line) into the livers. Drug treatments began on Day 14 after HCC cell implantation, when tumors were approximately 15% of their final, end-of-study size. Mice received either once-daily, orally administered rencofilstat; twice-weekly, intraperitoneally administered anti-PD1 antibody; or a combination of both rencofilstat and anti-PD1. In the first study arm, drugs were administered from Day 14 to Day 28 post-tumor cell implantation, followed by measurement of liver tumor size. In the second study arm, drugs were administered from Day 14 post-tumor cell implantation until ethical euthanasia or death of the mice resulting from tumor growth.

Neither rencofilstat nor anti-PD1 administered alone altered the size of tumors at Day 28, nor the survival of the mice compared to vehicle treatment. In contrast, combination treatment of rencofilstat plus anti-PD1 decreased tumor size by 69% at Day 28 (p=0.022) and increased median mouse survival time by 26% (vehicle 19.5 days; rencofilstat + anti-PD1 24.5 days; p=0.0011), compared to vehicle treatment. A robust anti-tumor effect from the drug combination, but not from monotherapy treatments, is an indication of rencofilstat and anti-PD1 synergy.

“Anti-PD1 therapies that stimulate immune cell attack on cancer cells are approved and effective in many types of cancer, but they have had limited success in HCC clinical trials. The lack of clinical outcomes success may be partly due to the occurrence of HCC in individuals that also have non-alcoholic fatty liver disease (NAFLD) or the more advanced form of the disease, NASH. NAFLD and NASH are both highly prevalent across the globe, and recent reports indicate that a fatty liver environment blocks the efficacy of anti-PD1 drugs, and perhaps other checkpoint inhibitors. In addition, as successful treatments for viral hepatitis have been implemented, NASH has been quickly becoming the leading cause of HCC,” said Daren Ure, PhD, Hepion’s Chief Scientific Officer.

Dr. Ure continued, “In agreement with this known limitation of these drugs, our own studies found that treatment with either anti-PD1 or rencofilstat alone in the hep53.4 HCC model decreased tumor growth by 76% when tumorigenic cells were implanted into non-fatty livers1 but were not effective as monotherapies in fatty livers in the current study. It is also significant to note that rencofilstat in combination with anti-PD1 not only decreased tumor growth, but also extended the survival of the mice in this very aggressive model of HCC. We are continuing to study the mechanisms underlying the synergistic effect of rencofilstat and anti-PD1.”

Robert Foster, PharmD, PhD, Hepion’s CEO, further commented, “HCC is the most common type of liver cancer. It has a poor prognosis compared to many other types of cancer, claiming approximately 800,000 lives annually across the globe. Although a few therapeutic compounds have been approved for non-resectable HCC, response rates are still low and there remains an urgent need for new, safe, and effective anti-HCC therapies. We were excited to have received authorization from the U.S. Food and Drug Administration last month to move directly into a Phase 2a study of rencofilstat for the treatment of HCC, and have already begun preparations to initiate that trial in parallel with our Phase 2b NASH clinical program in H2-2022. As far as we are aware, rencofilstat is the only drug in development that is being clinically evaluated in these two severe, and often comorbid liver indications.”

Reference

1 https://www.globenewswire.com/news-release/2021/11/16/2335363/0/en/Hepion-Pharmaceuticals-and-FibroFind-Announce-Anti-Cancer-Activity-of-CRV431-in-a-Nonclinical-Liver-Cancer-Study.html

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 soon followed in December 2021 by the FDA’s acceptance of Hepion’s investigational new drug (IND) application for rencofilstat for the treatment of hepatocellular carcinoma (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.

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, 2020, 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

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