Hepion Pharmaceuticals to Deliver Updates on Ongoing Phase 2 NASH Clinical Program with Rencofilstat at 6th Global NASH Congress

Rhea-AI Summary

Hepion Pharmaceuticals (NASDAQ:HEPA) announced that Chief Medical Officer Todd Hobbs will present an update on the NASH clinical program for rencofilstat at the Global NASH Congress on March 3, 2023. The presentation will cover the ASCEND-NASH and ALTITUDE-NASH trials, focusing on timelines and progress. The ASCEND-NASH trial, involving 90 sites across North America and Europe, aims for complete enrollment within 12 months. The ALTITUDE-NASH trial reached full enrollment in December 2022, with topline results expected in Q2 2023. The FDA has granted Fast Track and Orphan Drug designations for rencofilstat, highlighting its potential for treating NASH and HCC.

Positive

• Ascend-NASH trial screening initiated at up to 90 sites, with on-target enrollment expected within 12 months.
• Full enrollment of ALTITUDE-NASH trial achieved in December 2022, with topline results expected in Q2 2023.
• FDA Fast Track and Orphan Drug designations granted for rencofilstat, enhancing its market potential.

Negative

• None.

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 fibrotic diseases, including non-alcoholic steatohepatitis (“NASH”), hepatocellular carcinoma (“HCC”), and other chronic diseases, announces that its Chief Medical Officer, Todd Hobbs, MD, will be presenting “Rencofilstat (CRV431): Update on NASH Clinical Program,” on Friday, March 3^rd at the 6^th Global NASH Congress held in London, England.

Dr. Hobbs will be reviewing the status and timelines for the ongoing phase 2 NASH studies with its lead drug candidate, rencofilstat:

• ASCEND-NASH: a 12-month Phase 2b clinical trial in biopsy-proven F2/F3 NASH subjects
• ALTITUDE-NASH: a 4-month Phase 2 liver function trial in NASH F3 subjects

The ASCEND-NASH trial screening and enrollment has been initiated in up to 90 sites in North America and Europe, with all screening biopsies being evaluated in a three pathologist panel read strategy, preferred by regulatory authorities to reduce individual reader bias interpreting the paired biopsy samples. The study is currently recruiting well, and on target to fully enroll within approximately the next 12 months. A planned efficacy interim analysis is also targeted within this timeframe.

Full enrollment of the ALTITUDE-NASH trial was achieved in December 2022, and all subjects are on track to complete the study in mid-April 2023. Topline results will be available in Q2, 2023 once all data has been analyzed. During the Congress, baseline characteristics will be presented indicating that the enrolled NASH subjects are representative of an advanced fibrosis (F3) population.

“We are very pleased to once again be selected to present details on Hepion’s clinical programs at the Global NASH Congress,” commented Dr. Hobbs. “The Hepion clinical team and partner investigators have been working diligently to complete both the ALTITUDE-NASH and the ASCEND-NASH trials, which will allow a thorough evaluation of rencofilstat’s impact in NASH subjects with advanced fibrosis. This year will clearly be a pivotal year for revealing how rencofilstat may improve those living with this serious disease.”

A copy of Dr. Hobbs’ presentation 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 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 are the key updates from Hepion Pharmaceuticals regarding rencofilstat's NASH clinical program?

Hepion's CMO will present updates on two trials, ASCEND-NASH and ALTITUDE-NASH, at the Global NASH Congress on March 3, 2023.

When are the results expected for the ALTITUDE-NASH trial?

Topline results for the ALTITUDE-NASH trial are expected in Q2 2023.

What is the significance of the ASCEND-NASH trial for Hepion Pharmaceuticals?

The ASCEND-NASH trial is a pivotal study involving 90 sites, crucial for assessing rencofilstat's effectiveness in treating NASH.

What regulatory designations has rencofilstat received?

Rencofilstat has received Fast Track and Orphan Drug designations from the FDA for treating NASH and HCC.

How does the AI-POWR™ platform contribute to Hepion's NASH program?

AI-POWR™ aims to identify NASH patients likely to respond to rencofilstat, potentially shortening development timelines.