EDISON, NJ / December 9, 2019 / Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a biopharmaceutical company focused on the development of therapeutic drugs for the treatment of liver disease arising from non-alcoholic steatohepatitis (“NASH”), today announced that it will present two posters at the HEP DART 2019, Frontiers in Drug Development for Hepatology, Including Viral Hepatitis, NASH and Co-Infections meeting to be held in Kauai, HI from December 8-12, 2019.
The presentations will: 1) summarize the population pharmacokinetics (“PK”) of Rencofilstat obtained from a Phase 1 clinical study of healthy human subjects, and; 2) review Rencofilstat’s therapeutic actions in multiple experimental models of liver disease. The findings from the PK presentation will be utilized to establish Rencofilstat dosing in Phase 2 NASH clinical studies.
“Rencofilstat was safe and well tolerated in the Phase 1 single ascending dose study, and the PK analyses indicate that the drug can be administered as a fixed, once daily oral dose,” stated Dr. Patrick Mayo, Hepion’s Senior Vice President, Clinical Pharmacology. “The inter-patient variability was low, and no differences in PK were detected due to sex, age or body weight, which suggests that Rencofilstat would be convenient for both the patient and clinician.”
Dr. Daren Ure, Hepion’s Chief Scientific Officer added, “Every non-clinical study conducted to date with mice, rats, and human tissues has demonstrated that Rencofilstat decreases the extent of fibrotic liver scarring whether the injury to the liver was caused by dietary factors, toxins, or specific fibrosis-inducing cytokines. The combination of the comprehensive non-clinical and Phase 1 clinical data are very encouraging. It is our goal to develop Rencofilstat as a once-a-day versatile anti-fibrotic agent for NASH and other liver disorders.”
HEP DART, now in its 25th year, brings together international experts in hepatology and drug development to address the greatest therapeutic needs of the time. The central focus for many years has been chronic viral hepatitis but increasingly is expanding into NASH.
Presentation Details
Presentation #1: Population Pharmacokinetic (PopPK) Analysis of Rencofilstat in a Phase 1 Clinical Trial
Publication Number: P43
Authors: Mayo PR1, Trepanier D1, Ure D1, and Foster R1
1Hepion Pharmaceuticals, Inc.
Date: Tuesday, December 10, 2019
Time: 3:30 – 5:00 pm
Location: Grand Hyatt Kauai
Presentation #2: Anti-Fibrotic and Anti-Cancer Activities of the Cyclophilin Inhibitor, Rencofilstat, in Multiple Experimental Models of Liver Disease
Publication Number: P45
Authors: Ure D1, Kuo J2, Trepanier D1, Mayo P1, Gallay P2, and Foster R1
1Hepion Pharmaceuticals, Inc. 2The Scripps Research Institute, Department of Immunology and Microbiology
Date: Tuesday, December 10, 2019
Time: 3:30 – 5:00 pm
Location: Grand Hyatt Kauai
About Hepion Pharmaceuticals
Hepion Pharmaceuticals is a clinical stage biopharmaceutical company focused on the development of targeted therapies for liver disease arising from non-alcoholic steatohepatitis (NASH) and other types of hepatitis. The Company’s lead drug candidate, Rencofilstat, reduces liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH. Preclinical studies also have demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms. These diverse therapeutic activities result from Rencofilstat’s potent inhibition of cyclophilins, which are involved in many disease processes. Currently in clinical phase development, Rencofilstat shows potential to play an important role in the overall treatment of liver disease – from triggering events through to end-stage disease.
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; 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, 2018 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
SOURCE: Hepion Pharmaceuticals, Inc.
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