Biohaven Pharmaceutical Holding is on schedule to initiate a phase I pharmacokinetic and biomarker study with its lead drug development candidate BHV-0223. Biohaven plans to initiate the trial no later than 3Q2015. After confirming projected drug exposure levels in the phase I study, Biohaven will move directly into a phase III registrational trial in affective disorders.
BHV-0223 is a glutamate modulating agent being developed using Section 505(b)(2) of FDA guidelines. Section 505(b)(2) permits approval of new drug applications based, in part, upon prior findings of safety and/or effectiveness from a previously approved drug product. Biohaven has entered into an exclusive world-wide agreement with Catalent to provide its Zydis ODT fast-dissolve formulation for BHV-0223.
"The necessary work streams to begin our first phase I trial with BHV-0223 are well underway and remain on target for a study start in 3Q2015. Without any unforeseen delays, we anticipate a robust completion of the phase I study that will then enable a fully powered registrational phase III study to begin in early in 2016 with results available at the end of 2016 or first part of 2017," said Kimberly Gentile, vice-president of operations for Biohaven.