Biotech Values

[jbog]

Enanta discontinuing development of EDP-721


16:05 ENTA Enanta Pharmaceuticals 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. "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, CEO. "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."

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