Hepion Pharmaceuticals Announces Initiation of Phase 2b ‘ASCEND-NASH’ Trial

- Hepion Screens First Subject in Biopsy-Confirmed F2/F3 NASH Study -

- Subjects will be Evaluated on Three Doses of Rencofilstat for a One-year Period -

EDISON, N.J., Aug. 31, 2022 (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”), hepatocellular carcinoma (“HCC”), and other chronic liver diseases, today announced that it has screened the first subject in the ASCEND-NASH clinical trial. The trial is being conducted at up to 121 sites in seven countries, with 85 of the sites located within the U.S.

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 (“NIM”) will be assessed, including NASH efficacy biomarkers, magnetic resonance elastography (“MRE”), and multiomics (e.g. proteomics and transcriptomics).

“ASCEND-NASH represents the first time that rencofilstat is being studied in a biopsy confirmed-trial,” commented Todd Hobbs, MD, Hepion’s Chief Medical Officer. “We anticipate full enrollment in 12-to-14 months, as this is a large and rigorously controlled trial with a 60-day screening period including multiple laboratory analyses, Fibroscan evaluation, liver biopsy, and MRE. We will also be following the U.S. Food and Drug Administration-recommended utilization of a three-panel consensus to read all liver biopsies. As the study advances, our independent Data and Safety Monitoring Board will conduct two interim analyses. The first review will occur when one-third of study subjects have passed the six-month evaluation, and the second DSMB review will occur when one-third of subjects have completed the study and have had a final biopsy. Additionally, we received Fast Track designation from the FDA in November of 2021; this allows for the submission of study reports as they are obtained, as well as more frequent engagement with the Agency, which should provide for smoother transition from Phase 2b to Phase 3.”

“Initiation of screening in our Phase 2b ASCEND-NASH clinical trial represents a significant step forward for our company,” stated Robert Foster, PharmD, PhD, Hepion’s Chief Executive Officer. “For quite some time, our team has been busy setting the stage for this major clinical trial. Our efforts have focussed on ongoing optimization of drug manufacturing and product formulation; packaging; qualification of trial sites; and engagement with contract research organizations and regulatory agencies around the world. While these activities are time- and resource-intensive, it is gratifying to now see them culminate in the initiation of subject screening.”

Dr. Foster continued, “Finally, our goal is to create an ecosystem built around rencofilstat as the core asset. To that end, we are utilizing our proprietary AI-POWR™ tools to explore ways to create companion diagnostics to help identify which subjects may best respond to rencofilstat. We anticipate this approach of bundling rencofilstat with companion diagnostics will be advantageous when conducting future clinical trials, and developing a commercial strategy.”

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
[email protected]