NEW HAVEN, Conn., Oct. 28, 2019 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurologic and neuropsychiatric diseases, today announced that it has completed enrollment in its pivotal Phase 3 clinical trial assessing the efficacy and safety of troriluzole in generalized anxiety disorder (GAD). This multicenter, randomized, placebo-controlled, trial enrolled over 880 patients in less than nine months.
GAD is a chronic and long-lasting disorder in which a person has uncontrollable, excessive anxiety and worry and is often associated with significant functional impairment. According to the Anxiety and Depression Association of America (ADAA), millions of Americans suffer from GAD. If not appropriately treated, GAD has a chronic course associated with significant disability and high public burden. The current standard of care includes psychotherapy and medications including selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine inhibitors (SNRIs) and benzodiazepines. It is estimated that only approximately 30% of GAD sufferers fully respond to SSRI/SNRIs and the use of benzodiazepines can be associated with abuse, dependence and withdrawal symptoms.
Vlad Coric, M.D., CEO of Biohaven commented, "GAD is one of the most prevalent anxiety disorders seen in both primary care and specialist settings. We are hopeful that this Phase 3 study will demonstrate troriluzole's novel mechanism of action as a potential approach for addressing the debilitating consequences of GAD without the limitations associated with current treatments."
The primary outcome measure in this 8-week GAD trial with troriluzole is the change in a patient's score on the Hamilton Anxiety Rating Scale (HAM-A), a scale designed to assess the severity and type of symptoms in patients with GAD. The HAM-A is a widely used and validated scale that has served as the primary outcome measure to obtain approval in GAD both in the United States and globally. The trial will also assess the safety, tolerability and pharmacokinetics of troriluzole. Additional details about the trial can be found at www.clinicaltrials.gov.
Loren Aguiar, M.D., Vice President, Research and Development at Biohaven added, "We are grateful to the patients and clinical trial sites who helped us complete enrollment in this trial of troriluzole in less than nine months. The brisk study enrollment reflects the large numbers of patients who are not satisfied with their response on current therapies. We believe that troriluzole could be a promising alternative to current standards of care and look forward to topline results in the near term."
Troriluzole is a third-generation prodrug and new chemical entity that modulates glutamate, the most abundant excitatory neurotransmitter in the human body. The primary mode of action of troriluzole is reducing synaptic levels of glutamate. Troriluzole increases glutamate uptake from the synapse, by augmenting the expression and function of excitatory amino acid transporters (i.e., EAAT2) located on glial cells that play a key role in clearing glutamate from the synapse. More information about trorilzuole can be found at the Company's website link: https://www.biohavenpharma.com/science-pipeline/glutamate/troriluzole
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. 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. All statements, other than statements of historical facts, included in this press release, including the expected enrollment for the Company's Phase 3 trial of troriluzole, the potential results of the Company's Phase 3 trial of troriluzole in GAD, the potential for the Phase 3 trial to be a pivotal trial, the role of glutamate in GAD and the possible benefits of troriluzole compared to current standard of care for GAD patients, as well as the size of the potential market for troriluzole in GAD, are forward-looking statements. 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, 2018, as updated by the Company's subsequent Quarterly Reports on Form 10-Q. The forward-looking statements are made as of this date and the Company 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, Biohaven's Chief Executive Officer at [email protected]
SOURCE Biohaven Pharmaceutical Holding Company Ltd.