- Recently completed Phase 2 proof of concept study showed drug signal for troriluzole augmentation in OCD and pivotal Phase 3 trial now initiated
- Phase 3 trial enhancements include increased sample size to adequately power for previously observed treatment effect, higher dose of troriluzole and optimized clinical trial design to minimize placebo effect
- First patient successfully enrolled in the first of 2 planned troriluzole Phase 3 adjunctive trials in subjects with obsessive-compulsive disorder not responding to standard of care treatment
NEW HAVEN, Conn., Jan. 4, 2021
NEW HAVEN, Conn., Jan. 4, 2021 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven") today 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.
Elyse Stock, M.D., Chief Medical Officer commented, "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."
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.
Loren Aguiar, M.D., Vice President, Research and Development stated, "We are pleased to initiate our first Phase 3 study to advance the development of troriluzole in OCD. The prior proof-of-concept study provided valuable data for us to adequately power and design 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."
OCD is a serious psychiatric condition affecting over 2 million individuals in the U.S. and significantly impacts quality of life. It is a chronic and long-lasting disorder in which a person has uncontrollable, reoccurring thoughts (obsessions) and behaviors (compulsions). The current standards of care include behavioral therapy and selective serotonin reuptake inhibitors. It is estimated that 20-30% of OCD sufferers derive minimal benefit from current treatment options and continue to experience significant residual symptoms despite currently approved therapies.
Jeff Szymanski, PhD, Executive Director, International OCD Foundation added, "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."
Biohaven is a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, including rare disorders. Biohaven has combined internal development and research with intellectual property licensed from companies and institutions including Bristol-Myers Squibb Company, AstraZeneca AB, Yale University, Catalent, Rutgers, and ALS Biopharma LLC. Our progress is fueled by an entrepreneurial organizational structure and an impressive range of experience in drug development along with the confident support of top-tier biopharma investors. Currently, Biohaven's lead development programs include multiple compounds across its CGRP receptor antagonist, glutamate modulation, and myeloperoxidase inhibitor platforms. Biohaven's common shares are listed on the New York Stock Exchange and traded under the ticker symbol BHVN. More information about Biohaven is available at www.biohavenpharma.com.
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of the Company's management. The use of certain words, including the "believe" and "will" and similar expressions are intended to identify forward-looking statements. The Company may not actually achieve the plans and objectives disclosed in the forward-looking statements and you should not place undue reliance on the Company's forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements, including uncertainties relating to the future clinical success of troriluzole. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission on February 26, 2020 and Biohaven's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 filed with the Securities and Exchange Commission on November 9, 2020. The forward-looking statements are made as of this date and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
For further information, contact:
Dr. Vlad Coric
Chief Executive Officer
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.