Biohaven Begins Pivotal Phase 3 Trial Of Troriluzole In Obsessive-Compulsive Disorder
January 04, 2021 at 07:30 am
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Biohaven Pharmaceutical Holding Company Ltd. announced that it has commenced enrollment in a Phase 3 clinical trial assessing the efficacy and safety of troriluzole in patients with obsessive-compulsive disorder (OCD). Biohaven is advancing the 280 mg once daily dose of troriluzole into two double-blind, placebo-controlled Phase 3 clinical trials with identical study designs and plans to enroll approximately 600 patients in each of these adjunctive treatment trials across study sites in both the United States and Europe. A prior proof of concept study with adjunctive troriluzole in patients with OCD showed a clinically meaningful effect at all study timepoints in patients who had an inadequate response to existing standard of care treatment. Although the study sample size in Phase 2 did not demonstrate statistical significance, the data from the previous trial was instrumental in refining and powering the Phase 3 studies. Troriluzole is a new chemical entity and third-generation glutamate modulating agent that normalizes glutamate, a key neurotransmitter implicated in obsessive-compulsive disorder. Biohaven was awarded two U.S. Patents covering troriluzole, with international patents pending, all having statutory expiration dates in 2039. The primary mechanism of action of troriluzole is enhancing synaptic glutamate cycling by augmenting the expression and function of excitatory amino acid transporters (i.e., EAAT1-2) located on glial cells that play a key role in clearing glutamate from the synapse. Glutamatergic dysfunction is implicated in the pathophysiology of a broad range of disorders including OCD, Amyotrophic Lateral Sclerosis, Spinocerebellar Ataxia, Alzheimer's Disease, depression, chronic pain, and a variety of cancers. The therapeutic potential of troriluzole is supported by clinical and translational research studies.
Biohaven Pharmaceutical Holding Company Ltd. is a United States-based commercial-stage biopharmaceutical company. The Company has a portfolio of therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases, including rare disorders. The Company's Neuroinnovation portfolio includes NURTEC ODT (rimegepant) for the acute and preventive treatment of migraine and a pipeline of product candidates across five platforms: calcitonin gene related peptide (CGRP) receptor antagonism for the acute and preventive treatment of migraine as well as other pain-related disorders and non-migraine indications; glutamate modulation for obsessive-compulsive disorder (OCD); myeloperoxidase (MPO) inhibition for multiple system atrophy (MSA) and amyotrophic lateral sclerosis (ALS); Kv7 Ion Channel Activators (Kv7) to target indications including epilepsy, pain disorders and effective disorders; and Myostatin offers a natural protein that limits skeletal muscle growth.