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Hepion Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development and commercialization of pleiotropic drug therapy for the treatment of chronic liver disease. The company designs targeted therapies for liver disease arising from non-alcoholic steatohepatitis (NASH), hepatocelluluar carcinoma (HCC), and chronic hepatitis B, C, and D viruses (HBV, HCV, HDV). Hepion Pharmaceuticals was formerly called ContraVir Pharmaceuticals and spun-off from Synergy Pharmaceuticals through a SEC Form 10 filing in 2014. The company was founded on May 15, 2013 and is headquartered in Edison, NJ.
Hepion’s AI-POWR platform combines artificial intelligence, machine learning, and deep learning to decode disease, to develop targeted therapies, and to select patients that will respond to Hepion therapies. The platform provides an integrative, multi-variate, systems-biology bioinformatic, big-data analysis of pre-clinical and clinical data. AI-POWR utilizes publicly available databases to facilitate improved drug target selection, clinical study design, and a priori-responder analysis.
CRV431 is Hepion’s clinical phase, lead oral drug candidate for nonalcoholic steatohepatitis (NASH) and viral hepatitis-induced liver disease. The drug candidate is a host-targeting antiviral that reduces important viral proteins, such as those involved in host cell entry and viral replication. Specifically, CRV431 reduces liver fibrosis and hepatocellular carcinoma tumor burden and is a cyclophilin inhibitor that targets biochemical pathways involved in the progression of liver disease. As of May 2020, the drug candidate completed Phase 1 trials and advanced to Phase 2 trials for NASH fibrosis.
Hepion CRV431
On July 7, 2020, Hepion Pharmaceuticals announced that its clinical phase, anti-fibrotic drug candidate, CRV431, was efficacious in two distinct preclinical research models related to COVID-19 disease. Firstly, CRV431 demonstrated strong anti-inflammatory actions in a non-viral, acute lung injury model and on some measures outperformed dexamethasone, a recommended treatment for COVID-19. Secondly, cell culture experiments demonstrated CRV431 antiviral activity towards SARS-CoV-2, the virus responsible for COVID-19 disease. On December 22, 2020 the FDA approved Hepion Pharmaceuticals’ investigational new drug (IND) application for CRV431 as a treatment to COVID-19.
