The delay follows a standard 30-day review process associated with the investigational new drug (IND) application for the intravenous form of TBC3711, Encysive Pharmaceuticals’ next-generation selective endothelin receptor antagonist.
The FDA believes, and Encysive has agreed, that it requires further review before proceeding with patient dosing. All clinical testing with TBC3711, including oral and intravenous formulations, will be suspended.
Encysive said that the company will work with the FDA to resolve this issue as quickly as possible. Meanwhile, the biopharmaceutical firm’s stock has fallen by around 5% following the announcement.
TBC3711 has demonstrated encouraging kinetics in phase I studies and, based on the positive data for the company’s first endothelin A antagonist, sitaxsentan, TBC3711 is expected to hold promise as a next-generation compound. It will, therefore, be interesting to see what consequences this trial delay may have.