• Synergistic activity demonstrated with rencofilstat in combination with first line multiple myeloma drug, bortezomib 

EDISON, N.J., Jan. 18, 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 positive results of preclinical studies examining rencofilstat as a potential therapeutic for multiple myeloma (“MM”).

Rencofilstat exerted anti-cancer activity across a large panel of MM cell lines, and most potently, in combination with bortezomib, a proteosome inhibitor and first-line treatment for MM. These results strengthen Hepion’s oncology initiatives and further support rencofilstat’s poly-indication potential.

The combination of rencofilstat and bortezomib produced 100% cytotoxicity in cell culture experiments across all 16 MM cell lines, including three lines that are characterized as bortezomib-resistant. The cytotoxic activity of rencofilstat plus bortezomib was synergistic in every cell line, showing greater cytotoxicity in combination than the sum of the two drugs individually. Rencofilstat administered individually resulted in reduced cell numbers in most cell lines, and the suppressive effect of rencofilstat correlated to reduced gene expression levels of cyclophilins A and D, two of the known targets of rencofilstat. Most of the experiments were performed by Diag2Tec (Montpellier, France), a contract research organization with expertise in MM.

These results were consistent with an independent study that reported that cyclophilin A inhibition should be considered as a therapeutic strategy for resistant MM.¹ They were also similar to recent studies showing that a combination of rencofilstat and another proteosome inhibitor, ixazomib, synergistically killed prostate cancer cells. Together, they provide strong rationale for considering a rencofilstat-proteosome inhibitor combination for clinical investigation in MM or other cancers.

“These results provide further support for the development of rencofilstat as a therapeutic agent in oncology and other indications,” said Daren Ure, PhD, Hepion’s Chief Scientific Officer. “They validate years of research from the academic community documenting many therapeutic effects of cyclophilin inhibition. Rencofilstat’s antifibrotic activity is strongly linked to cyclophilin B inhibition, whereas its anti-cancer activity in the MM studies appears to depend on cyclophilins A and D. Interestingly, another entirely different mode of anti-cancer activity was previously highlighted in preclinical liver cancer studies, where rencofilstat exerted a synergistic, anti-tumor effect in combination with the checkpoint inhibitor, anti-PD1 antibody. Rencofilstat’s ability to target multiple processes as a single drug is one of its main advantages. Another key benefit is rencofilstat’s favorable safety profile in clinical trials to date, which creates opportunities for combining it with other drug therapies.”

Hepion has now documented beneficial effects of rencofilstat in experimental models of fibrosis in multiple organs, liver cancer, prostate cancer, thrombosis-related platelet activation, viral infections, lung injury, and MM.

Robert Foster, PharmD, PhD, Hepion’s Chief Executive Officer, stated, “While our two active Phase 2 clinical trials in NASH are Hepion’s major current focus, these latest results afford us the opportunity to continue to create a ‘pipeline within a product.’ Thorough scientific and strategic analyses are being conducted to characterize the growing list of disease indications that are possible candidates for rencofilstat treatment. At the same time, we are exploring additional business development initiatives and non-dilutive funding to support clinical trials in oncology, as recently announced.”

Reference

¹Nature Medicine, 2021 27(3):491-503. doi: 10.1038/s41591-021-01232-w

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
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