Hepion Pharmaceuticals Announces Publication of Food Effects Study with Rencofilstat

Hepion Pharmaceuticals, Inc.

EDISON, NJ, Oct. 20, 2022 (GLOBE NEWSWIRE) — Hepion Pharmaceuticals, Inc. (NASDAQ: HEPA), a clinical-stage biopharmaceutical company focused on developing artificial intelligence (“AI”)-driven therapeutic drugs for treatment of non-alcoholic steatohepatitis (“NASH”), hepatocellular carcinoma (“HCC”) and other fibrotic diseases, announced today that the peer-reviewed journal, Clinical pharmacology in drug developmentpublished the results of a clinical trial examining the effect of food on the oral bioavailability of rencofilstat, the Company’s lead drug candidate.

The article reviews a randomized, open-label, phase 1 trial in healthy subjects that evaluated the bioavailability of a single dose of rencofilstat in the fasting, high-fat state.

“This study showed that taking rencofilstat with a high-fat meal increases the absorption of this cyclophilin inhibitor and confirms the safety of the drug while offering patients the option of taking rencofilstat with or without food,” Patrick Mayo, PhD, Hepion Senior Vice President, Clinical and Analytical Pharmacology. “Increased absorption did not cause toxicity, and it is possible that increased exposure with food may improve the efficacy of rencofilstat in NASH and/or HCC patients who may be poor absorbers. medicine.”

“In past and ongoing clinical trials using rencofilstat, subjects took their daily dose on an empty stomach or with a small, low-fat meal,” said Hepion’s chief medical officer, Todd Hobbs, MD. “The results of this well-controlled food-effects study demonstrate that we can be comfortable administering rencofilstat under real-world, daily conditions with or without a meal.”

The article is available 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 is currently in clinical-stage development for the treatment of NASH, with the potential to play an important role in the overall treatment of liver disease – from initiating events to end-stage disease. Rencofilstat has been shown to reduce the tumor burden of liver fibrosis and hepatocellular carcinoma in experimental models of NASH, and has demonstrated antiviral activities against HBV, HCV and HDV by multiple mechanisms, in non-clinical studies. In November 2021, the United States Food and Drug Administration (“FDA”) granted Rencofilstat Fast Track designation for the treatment of NASH. This was followed in June 2022 by the FDA granting orphan drug designation to rencofilstat for the treatment of HCC.

Hepion has created a proprietary AI platform, called AI-POWR™, which stands for AArtificial intelligence – PMedicine; Omicros (including genomics, proteomics, metabolomics, transcriptomics and lipidomics); Oaccess to the global database; and Rresponse and clinical outcomes. Hepion intends to use AI-POWR™ to help identify NASH patients who will respond best to rencofilstat, potentially shortening development times 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 other potential indications for rencofilstat to expand the Company’s footprint in the therapeutic space of cyclophilin inhibition.

Forward-looking statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements can be identified by the use of forward-looking terms such as “anticipate”, “believe”, “expect”, ” estimated” and “intentional”, 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 these 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 funding; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties regarding lengthy and expensive clinical trials, as the results of past studies and trials may not be predictive of future trial results; uncertainties of reimbursement by the government or third-party payer; limited sales and marketing efforts and reliance on third parties; and risks related to the inability to obtain FDA clearances or approvals and non-compliance with FDA regulations. As with any drug candidate under development, the development, regulatory approval and commercialization of new products involve significant risks. There is no guarantee that any 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 commercial success. Hepion Pharmaceuticals does not undertake to update or revise any forward-looking statements. Investors should read the risk factors set forth in Hepion Pharmaceuticals’ Form 10-K for the fiscal year ended December 31, 2021 and other periodic reports filed with the Securities and Exchange Commission.

For more information, please contact:

Stephen Kilmer
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580
[email protected]

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