Hepion Pharmaceuticals reports developments around its transition into precision diagnostics, with a focus on blood-based tests for hepatocellular carcinoma and other disease areas. Company updates include the ctRNA biomarker assay licensed for early diagnosis and surveillance of HCC, the mSEPT9 PCR-based assay for liver cancer detection, and diagnostic test categories covering celiac disease, respiratory multiplex testing, H. pylori, and HCC.
Hepion news also covers public-company status changes and capital actions, including OTCQB trading, reverse stock split activity, Nasdaq delisting developments, leadership changes, stockholder voting matters, and the completed sale of rencofilstat-related patent assets, knowhow, clinical trial data, and drug product.
Hepion Pharmaceuticals (NASDAQ:HEPA) appointed Dr. Eddie C. Cheung to lead Strategic Medical Affairs in Asia, advancing the development of rencofilstat for NASH and hepatocellular carcinoma (HCC). Dr. Cheung's extensive experience in gastroenterology and hepatology will facilitate partnerships and regulatory interactions in Asia. His role is crucial given that over 75% of global liver cancer cases occur in Asia, with China accounting for a significant portion. Hepion aims to leverage AI-POWR™ to enhance treatment strategies for NASH and expand its therapeutic reach.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced that CEO Dr. Robert Foster will present at the BIO CEO & Investor Conference on February 15, 2022, at 11:15 AM ET in New York. The presentation will focus on the company's lead drug candidate, rencofilstat, which targets non-alcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC). This candidate has received FDA Fast Track designation and shows promise in reducing liver fibrosis and tumor burden. Hepion's proprietary AI platform, AI-POWR™, aims to optimize treatment strategies for NASH patients.
Hepion Pharmaceuticals announced promising results for its drug candidate rencofilstat (CRV431) in treating liver cancer in a recent study. Conducted alongside Newcastle University, the research revealed that combining rencofilstat with an anti-PD1 antibody significantly reduced tumor growth by 69% and increased survival time in mice by 26%. This combination therapy addresses the challenges posed by non-alcoholic fatty liver disease, which can hinder anti-PD1 treatment efficacy. Hepion has FDA approval to initiate a phase 2a study for rencofilstat in hepatocellular carcinoma.
Hepion Pharmaceuticals (NASDAQ:HEPA) sadly reports the passing of Thomas Adams, Ph.D., a Board member, on January 9, 2022. Dr. Adams, who joined the Board in September 2016, was a renowned figure in biotechnology. The Chairman, Gary S. Jacob, expressed condolences, emphasizing Adams' significant contributions and impact on the company. Hepion's lead drug candidate, rencofilstat, is advancing in clinical-phase development for NASH and has received Fast Track designation from the FDA. The company is leveraging its AI platform, AI-POWR™, to enhance patient response in treatment and explore additional indications for rencofilstat.
Hepion Pharmaceuticals announced that the USAN Council has adopted the name rencofilstat for its lead drug candidate, CRV431, aimed at treating non-alcoholic steatohepatitis (NASH) and liver diseases. This name will be used in future publications and presentations as the company advances clinical development. Rencofilstat is a potent cyclophilin inhibitor, showing promise in reducing liver fibrosis and tumor burden in NASH models. The FDA granted Fast Track designation for rencofilstat in November 2021 and accepted its IND application for hepatocellular carcinoma in December 2021.
Hepion Pharmaceuticals (NASDAQ:HEPA) is set to participate in the virtual H.C. Wainwright BioConnect Conference from January 10-13, 2022. The company will offer a pre-recorded presentation available on-demand for registered attendees and on its website starting January 10. Hepion's lead drug candidate, CRV431, is in clinical development for treating non-alcoholic steatohepatitis (NASH), aiming to mitigate liver disease impacts. The company leverages its AI platform, AI-POWR™, to enhance patient selection and potentially expedite drug development timelines.
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), announced that its Chief Medical Officer, Dr. Todd Hobbs, will present data from the Phase 2 AMBITION study at the NASH-TAG 2022 Conference on January 8, 2022. The presentation, titled 'Investigating CRV431 in NASH Patients: Data from the Phase 2a AMBITION Study,' was selected as one of the nine 'distinguished' abstracts for oral presentation. The company's lead drug candidate, CRV431, targets non-alcoholic steatohepatitis (NASH) and shows potential in reducing liver fibrosis and tumor burden in experimental models.
Hepion Pharmaceuticals has received FDA clearance for its investigational new drug (IND) application for CRV431, aimed at treating hepatocellular carcinoma (HCC). This IND allows CRV431 to advance directly into Phase 2 trials, complementing its existing development for non-alcoholic steatohepatitis (NASH). The drug, which is orally administered, has shown positive results in earlier trials and is designed to target liver disease effectively. Its potential benefits include enhanced patient experience and reduced side effects compared to traditional cancer therapies.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced that the FDA granted Fast Track designation for its lead drug candidate, CRV431, in treating non-alcoholic steatohepatitis (NASH). This designation enables expedited approval reviews and facilitates early communication with the FDA. CRV431 has shown efficacy in early clinical trials and is set to enter a larger Phase 2b study called ASCEND-NASH. Given that approximately 5% of U.S. adults have NASH and no FDA-approved treatments exist, this designation is significant for advancing CRV431 to market.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced promising nonclinical research results for its lead drug CRV431, which significantly reduced liver tumor growth in a mouse model. The study demonstrated that CRV431 decreased tumor size by 76%, rivaling an anti-PD1 antibody, while a combination treatment further improved outcomes by 83%. Additionally, CRV431 positively altered immune cell populations in tumors, suggesting enhanced anti-cancer activity. These findings support CRV431’s potential for treating hepatocellular carcinoma and non-alcoholic steatohepatitis, addressing urgent medical needs.