Hepion Pharmaceuticals to Present Phase 2a Rencofilstat Multiomics Data at NASH-TAG 2023

Rhea-AI Summary

Hepion Pharmaceuticals (NASDAQ:HEPA) announced that its lead drug candidate, rencofilstat, will be presented at the NASH-TAG 2023 Conference from January 5-7, 2023. The presentation, titled Rencofilstat Multiomics Data Indicate Clinically Important Mechanisms in NAFLD-NASH, highlights the drug's potential in treating fibrotic diseases like NASH and HCC. Rencofilstat has shown to reduce liver fibrosis and cancer tumor burden while receiving Fast Track and Orphan Drug designations from the FDA, indicating its promising therapeutic potential.

Positive

• Rencofilstat received Fast Track designation from the FDA for treating NASH.
• The drug demonstrated significant potential to reduce liver fibrosis and hepatocellular carcinoma tumor burden in preclinical studies.
• The AI-POWR™ platform may enhance patient response identification and shorten development timelines.

Negative

• None.

EDISON, N.J., Jan. 05, 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 fibrotic diseases, including non-alcoholic steatohepatitis (“NASH”), hepatocellular carcinoma (“HCC”), and other chronic diseases, today announced that an abstract highlighting its lead drug candidate, rencofilstat, will be presented at the NASH-TAG 2023 Conference, which is being held January 5-7, 2022, in Park City, Utah.

Presentation Details

Title: Rencofilstat Multiomics Data Indicate Clinically Important Mechanisms in NAFLD-NASH

Authors: Mayo PR, Harrison SA, Hobbs T, Zhao C, Foster E, Canizares C, Ure D, Trepanier D, Foster R

Date: Saturday, January 7, 2023

Time: 09:40 MST

“Multiomics integration provides a wholistic view of drug-disease interaction,” said Patrick Mayo, PhD, Hepion’s Senior Vice President, Clinical Pharmacology & Analytics. “It has allowed Hepion to uncover a complete network of rencofilstat activity in NASH and other fibrotic diseases. Critically, it allows us to determine responders versus non-responders, key genetic drivers, and biomarkers for NASH and other disease states. We have learned that rencofilstat alters key drivers in the currently understood NASH pathway with augmented activity outside of currently proposed paradigms. This also opens the doors for rational synergistic strategies.”

A copy of the presentation materials will be accessible on the Company’s website at www.hepionpharma.com under “Publications” in the Pipeline section.

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

FAQ

What is the purpose of Hepion's rencofilstat?

Rencofilstat is being developed for the treatment of fibrotic diseases, notably NASH and hepatocellular carcinoma.

When is the presentation about rencofilstat at the NASH-TAG 2023 Conference?

The presentation will take place on January 7, 2023, at 09:40 MST.

What designations has rencofilstat received from the FDA?

Rencofilstat received Fast Track and Orphan Drug designations for the treatment of NASH and HCC.

How does rencofilstat work to treat liver diseases?

Rencofilstat is a potent cyclophilin inhibitor that reduces liver fibrosis and targets mechanisms associated with chronic liver disease.

What are the implications of using AI-POWR™ in Hepion's clinical development?

AI-POWR™ aims to identify patient responders to rencofilstat, potentially leading to faster development timelines and improved treatment outcomes.