– Generalized anxiety disorder impacts approximately 7 million U.S. adults annually and many do not fully respond to current therapies

– Troriluzole is a new chemical entity that modulates glutamate in an effort to reduce the severity of anxiety, worry and functional impairment of people with anxiety

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

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, 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.