EDISON, N.J., March 16, 2023 — 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 Executive Officer, Robert Foster, PharmD, PhD, and its Senior Vice President for Clinical Pharmacology and Analytics, Patrick Mayo, PhD, will be presenting during a webinar entitled “How Artificial Intelligence is Changing Drug Discovery” on Thursday, March 23rd at 1:00 p.m. Eastern Time.
“We are honored to be invited to participate in this webinar designed to provide a current perspective of the AI landscape and what may lie ahead,” commented Dr. Foster. “We are particularly looking forward to highlighting our proprietary AI-POWR™ platform, which provides integrative, multi-variate, systems-biology bioinformatic and big-data analysis of proprietary pre-clinical and clinical data with publicly available multi-omic databases to facilitate improved drug target selection, clinical study design, and a priori responder analysis.”
Dr. Mayo added, “Through AI-POWR™, we were able to harness the power of AI and machine learning to combine a vast array of multi-omic data already available in NASH with the data from the Phase 2a ‘AMBITION’ clinical trial of our lead drug candidate, rencofilstat. That resulted in our identification of rencofilstat biomarkers revealing which patients may best respond to our drug candidate. This has already been validated on clinically relevant biomarkers, ALT and ProC3. Data from the Phase 2a study was used to design the ongoing Phase 2b ‘ASCEND-NASH’ trial which is aimed to validate the current biomarkers with other clinically relevant outcomes and liver histopathology. Ultimately, we anticipate this approach could allow for enrichment and de-risking of our Phase 3 study and provide AI-based dosing strategies for the commercial use of rencofilstat in NASH.”
The webinar is being co-produced by the American Chemical Society and the Joseph Priestley Society at the Science History Institute. The live webinar is free for all interested parties, but registration via this link is required. Following the event, a webcast archive will be posted on the Company’s website at www.hepionpharma.com under “Events” in the Investors 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
