Biohaven Enrolls First Patient in Phase 3 Troriluzole Trial

Biohaven has enrolled its first patient in a Phase 3 clinical trial assessing the efficacy and safety of troriluzole in generalized anxiety disorder (GAD).

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.

"Existing medications for GAD primarily target the neurotransmitters serotonin or gamma-aminobutyric acid (GABA)," Vlad Coric, M.D., CEO of Biohaven said. "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.

"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," Sanjay Mathew, M.D., Professor of Psychiatry and Behavioral Sciences and Vice Chair for Research at Baylor College of Medicine said. "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.

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