Business
Enanta Pharmaceuticals Announces Update to its Hepatitis B Virus (HBV) Program
Discontinuing Clinical Development of EDP-721, an Oral HBV RNA Destabilizer Continuing to Focus on Development of EDP-514 in Combination Regimens as a
About this update from Enanta Pharmaceuticals, Inc.
[{"type":"text","content":"\nDiscontinuing Clinical Development of EDP-721, an Oral HBV RNA Destabilizer\n\nContinuing to Focus on Development of EDP-514 in Combination Regimens as a Functional Cure for HBV\n\n WATERTOWN, Mass.--(BUSINESS WIRE)--\nEnanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced it is discontinuing development of EDP-721, an oral HBV RNA destabilizer, based on emerging safety observations in the single ascending dose part of a Phase 1 study in healthy volunteers.\n\n“Despite the clean preclinical safety profile demonstrated in comprehensive toxicology studies, safety signals were seen in healthy subjects after administration of EDP-721. Patient safety is our top priority, and we have therefore decided to discontinue further development of this compound,” said Jay R. Luly Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. “We are committed to developing a functional cure for chronic hepatitis B patients, and remain confident in EDP-514, our HBV core inhibitor, which has demonstrated safe and robust antiviral activity in Phase 1b studies of viremic and NUC-suppressed patients with chronic HBV infection. We believe core inhibitors will be an important component of a successful combination regimen, and we will look to advance our HBV program with additional mechanisms from internal discovery efforts, external opportunities, or both. Importantly, we are grateful to our Principal Investigator and his study team, and the participants in the Phase 1 study for their commitment to HBV research, and to our team for all their efforts in supporting the development and clinical evaluation of EDP-721.\"\n\nAbout Hepatitis B Virus\n\nHepatitis B is a viral infection that attacks the liver and can cause both acute and chronic disease. The virus is most commonly transmitted from mother to child during birth and delivery, as well as through contact with blood or other body fluids.1 It is estimated that over 290 million people worldwide have chronic HBV infection.2 Current approaches to treatment include interferon therapy and/or nucleos(t)ide reverse transcriptase inhibitors. Treatment with interferon offers poor cure rates and is accompanied by serious side effects.3 Nucleos(t)ide reverse transcriptase i...