• Hepion Enrolls 60 F3 NASH Subjects in only 12 weeks, facilitated by AGILE 3+ non-invasive test
• Hepion, Summit Clinical Research, and HepQuant Align to Deliver Rencofilstat’s Hepatic Function and NASH Biomarker Results by Q2, 2023

EDISON, N.J., Dec. 05, 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 fibrotic diseases, including non-alcoholic steatohepatitis (“NASH”), hepatocellular carcinoma (“HCC”), and other chronic diseases, today announced that it has completed enrollment of 60 NASH stage 3 (“F3”) subjects in the Phase 2 ALTITUDE-NASH clinical trial. The trial is being conducted in collaboration with HepQuant, LLC (“HepQuant”) and Summit Clinical Research (“Summit”), at 20 sites within Summit’s Integrated Research Organization.

ALTITUDE-NASH is a Phase 2, randomized, multi-center, open-label study designed to evaluate the safety and efficacy of rencofilstat on hepatic function and numerous NASH biomarkers after four months of dosing. Subjects enrolled in the trial were classified as NASH stage F3 based on either historical biopsy or by using the AGILE 3+ criteria, defined by a screening Fibroscan score alongside common clinical and laboratory parameters. Subjects are randomized to receive a once daily, oral dose of 75, 150, or 225 mg rencofilstat soft gelatin capsules (20 subjects in each dosing cohort) over a period of four months. The HepQuant ‘SHUNT’ test, a measure of hepatic function, will be performed at baseline, and changes in the Disease Severity Index (“DSI”) score relative to baseline measurements will be determined at days 60 and 120. Other NASH biomarkers will be collected throughout the study duration.

Stephen Harrison, MD, Chairman and Co-Founder of Summit, commented, “There was significant excitement throughout the network to enroll this study using the AGILE 3+ non-invasive test, which has recently been shown to be effective at identifying patients with advanced fibrosis due to NASH. We are thrilled that our integrated network of experienced NASH clinical trial sites used AGILE 3+ to enroll the study in record time and are eager to see how rencofilstat impacts hepatic function and other non-invasive assessments of liver injury.”

Greg Everson, MD, FACP, HepQuant’s Founder and Chief Scientific Researcher, said, “The enrollment rate of this NASH clinical trial has exceeded all expectations; 60 patients in 12 weeks is all but unprecedented. Notably, enrollment was accelerated by Hepion’s decision to propose improvement in liver function – measured using HepQuant’s technology – as an endpoint, eliminating liver biopsy as criteria for entry and for monitoring treatment effects. The vast majority of NASH investigators and sponsors are lamenting the costly problems of slow enrollment and high dropout rates, mainly related to dependency on liver biopsy. Hepion is suggesting an alternative, where demonstration of functional improvement, along with improvement in other non-invasive tests, could enable more rational study endpoints and facilitate the conduct of NASH trials.”

Todd Hobbs, MD, Hepion’s Chief Medical Officer, added, “Having initiated dosing in the larger and longer Phase 2b ‘ASCEND-NASH’ trial, Hepion’s priority is to use the ALTITUDE-NASH trial to understand the impact of three different doses of rencofilstat on NASH subjects, based on hepatic function and biomarkers. Modelling these results over the course of four months should allow us to better predict the outcome of the one-year, biopsy-confirmed ASCEND-NASH trial.”

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.

About HepQuant, LLC

Headquartered in Denver, Colorado, HepQuant is a privately held diagnostics company. HepQuant’s products are investigational combination drug and in-vitro diagnostic devices and have not yet been evaluated or reviewed by the U.S. Food and Drug Administration (“FDA”) for commercial sale. They are currently available for investigational use via the FDA guidelines for investigational device exemptions (IDEs). For additional information, visit www.hepquant.com

About Summit Clinical Research

Summit is a leading Integrated Research Organization, with a focus on non-alcoholic steatohepatitis (NASH) clinical trials. Through an innovative approach and the use of disruptive technologies, Summit delivers a full spectrum of study enrollment and site enrichment services to sites and scientific expertise to sponsors. With corporate offices in San Antonio, Texas, Summit brings together experienced clinical trial sites across the United States, in Europe and Latin America to execute clinical trials rapidly and with high quality data. For additional information, visit www.summitclinicalresearch.com.

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.