Hepion Pharmaceuticals Announces Passing of Key Safety Milestone in Phase 2b ‘ASCEND-NASH’ Trial of Rencofilstat

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 the Data and Safety Monitoring Board (“DSMB”) has met to review the current data for the ASCEND-NASH Phase 2b trial and has issued a “study may proceed without modification” clearance. This, the first planned DSMB meeting, occurred on schedule, and all labs, EKGs, adverse events, and protocol deviations were reviewed, focusing on any potential safety signals from the placebo-controlled trial. Hepion is on track to complete enrollment in ASCEND-NASH in the first quarter of 2024, and the initial subjects are now approaching the later stages of the 12-month trial.

“To date we have been pleased with the safety profile for all doses of rencofilstat in both healthy subjects and those with advanced NASH, most recently supported by the lack of safety signals in the 4-month phase 2 ‘ALTITUDE-NASH’ liver function trial,” said Todd Hobbs, MD, Hepion’s Chief Medical Officer. “Having an external group of experts review unblinded safety data from the ongoing and larger ASCEND-NASH biopsy trial and issue this clearance to continue without changes is reassuring for both Hepion and those subjects currently enrolled in the trial.”

About ASCEND-NASH

ASCEND-NASH is a Phase 2b, randomized, multi-center, double-blinded study to evaluate the safety and efficacy of rencofilstat in 336 subjects dosed for 12 months. Subjects included in the trial will be either F2 or F3 biopsy-confirmed, with enrollment of F3 subjects of at least 60%, to focus on NASH subjects with more advanced fibrosis. Subjects will receive either placebo or rencofilstat, administered orally once daily at doses of 75, 150, or 225 mg (n=84 subjects/cohort). Endpoints will evaluate improvements in both fibrosis and steatosis, with the overall study primary endpoint being an improvement of fibrosis score by one point without a worsening of steatosis, or an improvement of steatosis without worsening of fibrosis. Although the main trial endpoint is histologic and determined by changes in the biopsy, numerous other non-invasive markers will be assessed, including NASH efficacy biomarkers, magnetic resonance elastography, and multiomics (e.g., proteomics and transcriptomics).

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, 2022, and other periodic reports filed with the Securities and Exchange Commission.

For further information, please contact: Stephen KilmerHepion Pharmaceuticals Investor RelationsDirect: (646) [e-mail]