Hepion Pharmaceuticals Expands SAB with Appointments of Four Liver Disease KOLs

Rhea-AI Summary

Hepion Pharmaceuticals (NASDAQ:HEPA) has appointed four renowned experts to its Scientific Advisory Board (SAB) as of March 30, 2023. This move enhances the company’s expertise in liver disease research and drug development. The new members are Dr. Rohit Loomba, Dr. Vlad Ratziu, Dr. Yury V. Popov, and Dr. Nikolai Naoumov, each bringing extensive backgrounds in hepatology.

Their experience will support Hepion's clinical programs for rencofilstat, aimed at treating NASH and HCC. Rencofilstat is currently in Phase 2 trials, with FDA Fast Track and Orphan Drug designations. Hepion also employs an AI platform, AI-POWR™, to optimize patient outcomes in its drug development.

Positive

• Appointment of four leading experts to the Scientific Advisory Board enhances Hepion's research capabilities.
• Rencofilstat has received FDA Fast Track and Orphan Drug designations, positioning it favorably for market entry.

Negative

• None.

EDISON, N.J., March 30, 2023 (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, announces the addition of four new internationally recognized thought leaders to its Scientific Advisory Board (“SAB”), effective immediately.

These new members, who bring decades of liver disease research and drug development experience to the Hepion SAB, include:  

• Rohit Loomba, MD, a Professor of Medicine; Director of Hepatology; Vice Chief, Division of Gastroenterology; and Founding Director of the NAFLD (non-alcoholic fatty liver disease) Research Center at the University of California at San Diego (“UCSD”). He is the founding director of the UCSD NAFLD Research Center, where his team is conducting cutting edge research in all aspects of NAFLD, including non-invasive biomarkers, genetics, epidemiology, clinical trial design, imaging endpoints, and integrated OMICs using microbiome, metabolome and lipidome. Dr. Loomba has published more than 350 manuscripts and has an H-index of 99. He serves on the editorial boards of Gastroenterology, Journal of Hepatology, GUT, and Nature Reviews in Gastroenterology & Hepatology.
• Vlad Ratziu, MD, a Professor of Hepatology at Sorbonne University and Pitié-Salpêtrière Hospital in Paris, France. His main research interests are in the field of NAFLD; the mechanisms, risk factors, and progression of liver fibrosis in viral and metabolic diseases; and the treatment of viral hepatitis and HCC. He has participated in early-, mid-, and late-stage trials of NASH and has published more than 260 articles in prominent journals. He is a co-editor for the Journal of Hepatology and is an associate editor for Clinical Liver Disease.
• Yury V. Popov, MD, PhD, an Assistant Professor of Medicine at Beth Israel Deaconess Medical Center (“BIDMC”) and Harvard Medical School. He is also an Associate Editor of the American Journal of Physiology-Gastrointestinal and Liver Physiology, and an ad hoc reviewer for over 30 scientific journals. Dr. Yury Popov’s laboratory’s major research focus is on liver fibrosis/cirrhosis and its life-threatening sequelae. Specifically, his team investigates the basic mechanisms of progression and regression of liver scarring, with the goal of the development of non-invasive diagnostic tools to measure these processes in the clinic, and novel therapies to prevent and reverse cirrhosis and its life-threatening complications, such as primary liver cancers.
• Nikolai Naoumov, MD, PhD, a physician-scientist with a professional career spanning academia, clinical care, and drug development - all focused on liver diseases. He is Fellow of both the Royal College of Physicians (London) and the Royal College of Pathologists (UK). His research has integrated immunology, molecular biology and translational medicine in elucidating virus-host interactions and mechanisms of liver injury. Most recently, Dr. Naoumov expanded his contributions to medical science and clinical hepatology as Global Head, Therapeutic Area Hepatology and Transplantation at Novartis.

The new Hepion SAB members join existing members Stephen Harrison, MD (Chair) and Philippe Gallay, PhD.

“On behalf of everyone at Hepion, I would like to welcome Drs. Loomba, Ratziu, Popov and Naoumov to our team,” commented Robert Foster, PharmD, PhD, Hepion’s Chief Executive Officer. “They each bring a wealth of invaluable experience, which we will rely on to help make many key decisions related to our rencofilstat NASH clinical programs, as well as to guide other areas of interest in fibrosis related diseases.”  

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  

FAQ

What recent changes occurred in Hepion Pharmaceuticals' Scientific Advisory Board?

Hepion Pharmaceuticals appointed four new members with extensive experience in liver disease research to its Scientific Advisory Board.

What is the significance of rencofilstat in Hepion Pharmaceuticals' pipeline?

Rencofilstat is in Phase 2 development for NASH and has received FDA Fast Track and Orphan Drug designations, indicating its potential in treating liver diseases.

Who are the new members of Hepion Pharmaceuticals' Scientific Advisory Board?

The new members are Dr. Rohit Loomba, Dr. Vlad Ratziu, Dr. Yury V. Popov, and Dr. Nikolai Naoumov, all recognized experts in liver disease.

What is AI-POWR™ and how does it relate to Hepion Pharmaceuticals?

AI-POWR™ is Hepion's proprietary AI platform designed to enhance drug development and patient response in clinical trials for rencofilstat.

When was the press release regarding Hepion Pharmaceuticals' SAB changes issued?

The press release was issued on March 30, 2023.