EPO Decision to Grant European Patent for Rencofilstat Further Strengthens Hepion’s Patent Portfolio
Hepion Pharmaceuticals, Inc. recently announced 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 8 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, said “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.”
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.
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