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Biohaven Enrolls First Patient In Phase 3 Generalized Anxiety Disorder (GAD) Trial Of Troriluzole

- Troriluzole is a third-generation tripeptide prodrug and new chemical entity that modulates glutamate, the most abundant excitatory neurotransmitter in the human body

- The therapeutic potential of troriluzole in GAD is supported by clinical and translational research studies suggesting that glutamatergic dysfunction is implicated in the pathophysiology of anxiety disorders

NEW HAVEN, Conn., Feb. 20, 2019 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (BHVN), a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neuropsychiatric diseases, today announced that it has enrolled its first patient in a Phase 3 clinical trial assessing the efficacy and safety of troriluzole in generalized anxiety disorder (GAD).

Biohaven Pharmaceuticals Logo (PRNewsfoto/Biohaven Pharmaceutical Holding)

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), approximately 7 million Americans suffer from GAD. 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 experience remission from current SSRI/SNRI treatment options. In addition, the use of benzodiazepines can be associated with abuse, dependence and withdrawl symptoms. 

Vlad Coric, M.D., CEO of Biohaven commented, "Existing medications for GAD primarily target the neurotransmitters serotonin or gamma-aminobutyric acid (GABA). Novel treatment interventions are needed for this common anxiety disorder. Recent clinical and preclinical evidence provides support for the hypothesis that glutamate dysregulation may play an important role in the pathogenesis of anxiety disorders.  We are excited about exploring the efficacy of our glutamate modulating platform in the treatment of GAD."  

Biohaven expects to enroll approximately 372 patients in this randomized, double-blind, placebo-controlled trial across approximately 50 sites in the United States. Researchers will evaluate acute symptomatic treatment with troriluzole in patients with a diagnosis of generalized anxiety disorder. The primary outcome measure is the change in a patient's score on the Hamilton Anxiety Rating Scale, a scale designed to assess the severity and type of symptoms in patients with GAD. The trial will also assess the safety, tolerability and pharmacokinetics of troriluzole.  Additional details about the trial can be found at www.clinicaltrials.gov.

Sanjay Mathew, M.D., Professor of Psychiatry and Behavioral Sciences and Vice Chair for Research at Baylor College of Medicine commented, "GAD is one of the most common psychiatric disorders seen in the primary care setting and remains under recognized.  Emerging evidence, including preclinical animal models as well as neuroimaging and clinical studies, implicate glutamate as playing a role in anxiety symptomatology.  This study with troriluzole, a drug with a novel mechanism of action, is an important step in helping to elucidate this hypothesis and potentially provide a new treatment modality for GAD." 

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

Loren Aguiar, M.D., Vice President, Research and Development at Biohaven added, "We are pleased to begin this trial of troriluzole, a glutamate modulator, for the treatment of GAD.  Current therapies for this disorder are limited and are often not adequately effective.  As such, new treatments are urgently needed for this often disabling, chronic condition.  We believe that troriluzole could be a promising alternative to current standards of care and are pleased to have taken this important first step in further exploring its potential to treat GAD."

About Biohaven

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, ALS Biopharma LLC and Massachusetts General Hospital. 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.  

Forward-Looking Statements

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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 14, 2018. 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 Vlad.Coric@biohavenpharma.com

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