EPO Decision to Grant European Patent for Rencofilstat Further Strengthens Hepion’s Patent Portfolio

Rhea-AI Summary

Hepion Pharmaceuticals has announced the granting of European Patent No. EP 3886813 for its lead drug candidate, rencofilstat, covering 38 European countries. This patent extends the exclusivity period to potentially 2048, providing a crucial competitive advantage. This extension builds on Hepion’s existing patent portfolio, originally set to expire in 2036. Rencofilstat, which inhibits cyclophilins and targets conditions like NASH and HCC, is in Phase 2 clinical trials and benefits from both FDA Fast Track and Orphan Drug designations.

CEO Robert Foster emphasized the importance of this patent for protecting rencofilstat's market potential amidst growing interest from researchers.

Positive

• Granted European Patent No. EP 3886813 covering 38 countries.
• Patent extension expected to provide exclusivity until 2048.
• Existing patents set to expire in 2036, bolstering competitive advantage.
• Rencofilstat is in Phase 2 clinical trials with FDA Fast Track and Orphan Drug designations.

Negative

• None.

– Patent Covers 38 European Countries –

– Rencofilstat’s Exclusivity May Extend into 2048 –

EDISON, N.J., March 02, 2023 (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”), fibrotic diseases, hepatocellular carcinoma (“HCC”), and other chronic diseases, today announced that the European Patent Office (“EPO”) has granted European Patent No. EP 3886813, covering the innovative formulation of Hepion’s lead cyclophilin inhibitor, rencofilstat.

The newly granted European patent also significantly extends the time period of Hepion’s patent exclusivity for rencofilstat. The Company’s original composition-of-matter patent estate, comprising 52 patents issued in every major market throughout the world, are expected to provide exclusivity to 2036. The newly granted rights, which will encompass 38 European countries, are expected to extend the drug candidate’s patent life by approximately eight years, to 2044. Additional filings are also underway to potentially extend composition-of-matter and method-of-manufacturing exclusivity until 2048. In addition to the indications covered in the original composition-of-matter patents (viral, cardiovascular, neurological, and inflammatory diseases), Hepion has also filed various method-of-use patent applications covering a variety of additional indications (fibrosis, cancer, and thrombosis).

Robert Foster, PharmD, PhD, Hepion’s Chief Executive Officer, stated, “Rencofilstat is very challenging to formulate, owing to the physical-chemical properties of the molecule. Nevertheless, as awareness of its potential to address a number of significant unmet medical needs across a variety of indications continues to grow amongst researchers and drug developers in global markets, it is important this opportunity is well protected. To that end, our expanding intellectual property estate, including this new European patent, should ensure that rencofilstat has long-term market exclusivity.”

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, 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

FAQ

What does the newly granted European Patent for Hepion Pharmaceuticals cover?

The European Patent No. EP 3886813 covers the innovative formulation of Hepion’s lead drug candidate, rencofilstat, and extends exclusivity to 2048.

How many European countries are included in the new patent for rencofilstat?

The new patent applies to 38 European countries.

What are the implications of the patent extension for Hepion Pharmaceuticals?

The patent extension enhances Hepion's market exclusivity for rencofilstat, potentially increasing its competitive position and commercial viability.

What is the current phase of rencofilstat in clinical trials?

Rencofilstat is currently in Phase 2 clinical development, targeting non-alcoholic steatohepatitis (NASH).

What designations has the FDA granted for rencofilstat?

The FDA has granted Fast Track designation and Orphan Drug designation for rencofilstat for the treatment of NASH and hepatocellular carcinoma (HCC).