Hepion Pharmaceuticals Announces Publication of Food Effect Study with Rencofilstat
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA) has announced the publication of a peer-reviewed study in Clinical Pharmacology in Drug Development, which investigates food's impact on rencofilstat's bioavailability. The Phase 1 trial demonstrated that a high-fat meal enhances the absorption of rencofilstat without causing toxicity, suggesting the potential for improved efficacy in NASH and HCC patients. This flexibility in administration aligns with real-world conditions. Rencofilstat has received Fast Track and Orphan Drug designations from the FDA for its applications in NASH and HCC.
- Rencofilstat's bioavailability increases with high-fat meals, enhancing patient compliance.
- FDA granted Fast Track designation for rencofilstat for treating NASH.
- Rencofilstat received Orphan Drug designation for HCC, indicating potential market exclusivity.
- No guarantees on the success of future clinical trials or regulatory approvals.
- Competition and the need for additional financing pose risks to development.
EDISON, N.J., Oct. 20, 2022 (GLOBE NEWSWIRE) -- 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 fibrotic diseases, today announced that the peer-reviewed journal, Clinical Pharmacology in Drug Development, has published 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 Phase 1, randomized, open-label trial in healthy subjects which assessed the bioavailability of a single dose of rencofilstat in both fasted and high-fat conditions.
“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 providing the flexibility for patients to take rencofilstat with or without food,” Patrick Mayo, PhD, Hepion’s Senior Vice President, Clinical Pharmacology & Analytics. “The increased absorption did not cause toxicity, and it is possible the increased exposure with food could enhance rencofilstat’s efficacy in those NASH and/or HCC patients who may be poor absorbers of the drug.”
“In previous and ongoing clinical trials using rencofilstat, subjects take their daily dose either fasting or with a small, low-fat meal,” stated Hepion’s Chief Medical Officer, Todd Hobbs, MD. “The results from this well-controlled food effect study demonstrate that we can be comfortable with administration of rencofilstat under real-world, everyday conditions with or without a meal.”
The article may 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 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.
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.
For further information, please contact:
Stephen Kilmer
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580
skilmer@hepionpharma.com
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