Encysive's next-generation selective endothelin receptor antagonist TBC3711 is subject to a clinical hold following an unexpected result in pre-clinical work.

The hold was prompted by an "unusual finding" in a rat that received an intravenous dose of the experimental cardiovascular treatment, Encysive said March 23. The company noted the rat displayed abnormalities at baseline.

"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," the company said March 23.

An oral form of the drug has been given to 44 patients as part of a Phase I trial with no significant adverse events reported in the group, according to the company. Enrollment began in January for the 150-patient dose ranging trial.

The intravenous formulation has yet to be administered to humans.

Encysive TBC3711 On Clinical Hold

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