Encysive Pharmaceuticals delays studies with selective endothelin receptor antagonist TBC3711
Encysive Pharmaceuticals announced that Encysive and the U.S. food and Drug Administration (FDA) have placed TBC3711, the Company's next-generation selective endothelin receptor antagonist entering early clinical studies, on clinical hold. The hold is a result of an unusual finding following dosing with intravenous TBC3711 in a single rat that had displayed abnormalities at baseline. The delay follows a standard 30-day review process associated with the Investigational New Drug (IND) application for the intravenous form of TBC3711. The FDA believes, and the Company agrees, that it requires further review before proceeding with patient dosing. All clinical testing with TBC3711, including oral and intravenous formulations, will be suspended. Encysive will work with the FDA to resolve this issue as quickly as possible.
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