Biohaven and its wholly owned subsidiary, Biohaven Pharmaceuticals, Inc., announced the U.S. Food and Drug Administration (FDA) has notified the company that it may proceed with its clinical investigation of trigriluzole, a novel glutamate modulator, as a potential treatment for patients with obsessive-compulsive disorder (OCD). The FDA "May Proceed Letter" was received following Biohaven's filing of an investigational new drug (IND) application for this program, and the company expects to commence a Phase 2/3 clinical trial of trigriluzole in OCD in the current quarter.
"OCD is a serious neuropsychiatric disorder for which many patients do not have effective or tolerable therapy, and in which glutamate dysregulation may play a significant role. We are very pleased to explore the potential of trigriluzole as a safe and effective therapy for these patients as part of our mission to develop best-in-class and first-in-class therapies for patients with severe neurologic and neuropsychiatric diseases," said Vlad Coric, M.D., Chief Executive Officer of Biohaven.
OCD is a chronic and disabling condition characterized by symptoms of obsessions (intrusive thoughts) and compulsions (repetitive behaviors) that can interfere with patients' functional abilities. Current first-line drug treatment options include pharmaceutical agents which may be ineffective or produce significant side effects in many patients. Clinical evidence suggests that dysregulation of glutamate, which plays an essential role in normal brain functioning and is present in over 90% of brain synapses, may contribute to the underlying cause of OCD. Trigriluzole is a novel third-generation prodrug glutamate modulator representing more than six years of chemistry research and development involving over 300 drug candidates. Trigriluzole has been observed to have a favorable safety and tolerability profile in clinical trials. Exposure data from recent clinical experience with trigriluzole has helped inform the dosing of trigriluzole in the planned OCD Phase 2/3 trial.
Beyond its planned Phase 2/3 trial in OCD, Biohaven is making progress across its oral, small molecule calcitonin gene-related peptide (CGRP) receptor antagonist and glutamate modulation technology platforms.