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A new phase 3 trial recently started for the novel treatment troriluzole.
Biohaven Pharmaceutical Holding Company recently announced the start of a pivotal phase 3 clinical trial. It will assess the efficacy and safety of troriluzole for the treatment of obsessive-compulsive disorder (OCD).
“We look forward to advancing our Phase 3 clinical trials of troriluzole 280 mg for the adjunctive treatment of OCD. If approved, this would provide hope to many who suffer with OCD and for whom standard of care medications do not provide adequate relief. No new treatments for OCD have been approved for over two decades. With its novel mechanism of action compared to currently available therapies, troriluzole would provide a significant advance in treatment for the many patients who either do not respond or continue to experience residual symptoms with standard medications,” Elyse Stock, MD, Chief Medical Officer at Biohaven said to the press.1
Biohaven decided to advance the 280 mg once-daily dose of troriluzole into 2 identical, study-designed phase 3 clinical trials. They plan to enroll approximately 600 patients in each of these trials across study sites in both the United States and Europe. The recently completed phase 2 trial (a proof of concept study) showed clinically meaningful effects at all study timepoints in patients who had an inadequate response to standard treatment. While the study sample size in the phase 2 trial did not demonstrate statistical significance, the data was instrumental in refining the phase 3 studies.
“We are excited to begin these new studies as approximately one third of patients with OCD do not respond to currently available medications and new therapies are urgently needed. We believe troriluzole, which normalizes neuronal glutamate, could offer a promising alternative treatment with a new mechanism of action for OCD sufferers who are not adequately responding to currently available treatments,” Loren Aguiar, MD, Vice President of Research and Development and Biohaven said to the press.1
Troriluzole is a new chemical entity and modulating agent that normalizes glutamate. Biohaven was awarded 2 US patents covering troriluzole, and international patents are pending. All the patents have statutory expiration dates in 2039.
The executive director of the International OCD Foundation, Jeff Szymanski, PhD, had this to say: “There is a significant need for new treatments for those suffering from OCD. We applaud Biohaven for their ongoing research and moving forward with these upcoming trials.”1
1. Biohaven. Biohaven begins pivotal phase 3 trial of troriluzole in obsessive-compulsive disorder. News release. January 4, 2021. https://www.biohavenpharma.com/investors/news-events/press-releases/01-04-2021