Hepion Pharmaceuticals Announces Initiation of Dosing in Phase 2 ‘ALTITUDE-NASH’ Liver Function Trial

Rhea-AI Summary

Hepion Pharmaceuticals has initiated a Phase 2 clinical trial for rencofilstat, targeting non-alcoholic steatohepatitis (NASH). The ALTITUDE-NASH study will assess 60 adult subjects over four months, with doses of 75, 150, or 225 mg. The trial's goal is to evaluate hepatic function using HepQuant's SHUNT test and other NASH biomarkers. This collaboration with HepQuant and Summit Clinical Research highlights the pressing need for effective NASH treatments, as the disease poses significant health risks without FDA-approved therapies.

Positive

• The Phase 2 trial involves multiple dosing levels, offering comprehensive data on rencofilstat's efficacy.
• Rencofilstat has previously shown potential in reducing liver fibrosis and tumor burden in NASH models.
• The trial utilizes non-invasive testing methods, providing valuable insights into liver function without invasive biopsies.

Negative

• NASH currently lacks FDA-approved therapies, indicating potential market challenges.
• There may be significant risks associated with lengthy and expensive clinical trials.

- Hepion Collaborates with HepQuant and Summit Clinical Research to Evaluate Rencofilstat’s Impact on Hepatic Function and Numerous NASH Functional Biomarkers -

- F3 NASH Subjects will be Evaluated on Three Doses of Rencofilstat for a Four-month Period -

EDISON, N.J., Sept. 12, 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 dosed the first NASH stage 3 (“F3”) subject with rencofilstat in a Phase 2 clinical trial designed to measure hepatic function. The trial is being conducted in collaboration with HepQuant, LLC, (“HepQuant”) and Summit Clinical Research (“Summit”), at up to 20 sites within Summit’s Integrated Research Organization.

ALTITUDE-NASH is a Phase 2, randomized, multi-center, open-label study to evaluate the safety and efficacy of rencofilstat in 60 adult subjects. Subjects included in the trial will be presumed F3, based on either historical biopsy or by using the AGILE 3+ criteria as defined by a screening Fibroscan score alongside common clinical and laboratory parameters. Subjects will be 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 Disease Severity Index (“DSI”) relative to baseline measurements will be determined at days 60 and 120. Other NASH biomarkers will be collected throughout the study duration.

“When evaluating hepatic drug efficacy, clinicians and regulatory agencies rely on the assessment of many parameters, including liver fat content, inflammation, ballooning, and fibrosis, which require an invasive liver biopsy,” stated Greg Everson, MD, CEO and Chief Medical Officer of HepQuant. “Although biopsy is the gold standard, it measures only surrogates to liver function and does not truly determine the extent of hepatic impairment or improvement with clinical interventions. HepQuant’s non-invasive, blood-based technology determines a DSI score that relies on liver-specific uptake of cholate to measure hepatic and portal blood flow; and portal-systemic shunt in patients with chronic liver disease, providing a direct assessment of liver function and physiology. To date, HepQuant’s procedure has been successfully utilized in 26 studies with over 1,100 subjects.”

Stephen Harrison, MD, President of Summit, commented, “NASH is the most rapidly increasing indication for liver transplantation in the U.S., and is a leading cause of end-stage liver disease and liver transplantation in adults under the age of 50. Up to one-third of adults around the world have non-alcoholic fatty liver disease and data within the United States suggest that up to 14% of adults have NASH, a serious liver disease that may progress to cirrhosis and is currently without an FDA approved therapy. Given this major unmet medical need, I welcome any advance in the treatment of this serious condition. As a hepatologist and gastroenterologist, I also look forward to the development and adoption of non-invasive testing methods that are able to assess liver function accurately and reliably.”

Todd Hobbs, MD, Hepion’s Chief Medical Officer, added, “Following the positive Phase 2a ‘AMBITION’ trial data readouts, Hepion’s clinical team has spent the better part of the last year preparing for the start of what we expect to be two very informative clinical trials in NASH F3 subjects. The ALTITUDE-NASH trial will offer a very sensitive measure of hepatic function at all three doses of rencofilstat. When combined with data from the recently announced Phase 2b ‘ASCEND-NASH’ paired-biopsy trial in F3 subjects, data from ALTITUDE-NASH will provide us with a better understanding of how rencofilstat impacts several key NASH biomarkers.”

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.

For further information, please contact:

Stephen Kilmer
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580
skilmer@hepionpharma.com

FAQ

What is the goal of Hepion's Phase 2 clinical trial for rencofilstat?

The trial aims to evaluate the safety and efficacy of rencofilstat in measuring hepatic function in NASH patients.

What are the dosing levels for rencofilstat in the ALTITUDE-NASH study?

Participants will receive once-daily doses of 75, 150, or 225 mg of rencofilstat.

What is the significance of the SHUNT test in the study?

The SHUNT test provides a non-invasive measure of hepatic function, which is key to assessing treatment efficacy.

How many subjects will be enrolled in the ALTITUDE-NASH trial?

The trial will enroll 60 adult subjects diagnosed with stage 3 NASH.

What is the importance of non-alcoholic steatohepatitis (NASH) in healthcare?

NASH is a leading cause of liver disease and transplantation, affecting up to 14% of adults in the U.S.