US-based Biohaven Pharmaceutical is set to initiate a Phase II/III clinical trial of its product candidate trigriluzole for the treatment of patients with obsessive-compulsive disorder (OCD).
The firm has received approval from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application to start clinical investigations of the candidate for OCD.
Being a substrate for the gut transporters (PepT1), trigriluzole is a glutamate modulator designed to improve bioavailability.
The product candidate is developed as a once-daily dose to ensure compliance and long-term outcomes.
Biohaven Pharmaceutical CEO Vlad Coric said: "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.”
In previous clinical trials, trigriluzole is reported to have demonstrated favourable safety and tolerability profile, and the dosing regimen in Phase II/III trial is based on recent clinical findings of the candidate.
Trigriluzole is being further studied in a long-term, 48-week extension study for patients with SCA.
Apart from trigriluzole, the firm is evaluating another investigational drug rimegepant in a Phase III clinical trial for the treatment of migraine with top-line results scheduled to be available in the first quarter of next year.
Additionally, Biohaven intends to initiate a bioequivalence study for BHV-0223 by the end of this year in amyotrophic lateral sclerosis (ALS) patients.