Biohaven Enrolls First Patient in Rimegepant Phase 2 Clinical Trial

Biohaven announced that the first patient has been enrolled in a Phase 2 clinical trial assessing the efficacy and safety of rimegepant in treatment refractory trigeminal neuralgia.

Trigeminal neuralgia is a neuropathic pain disorder characterized by recurrent, paroxysmal, lancinating pain in the distribution of one or more branches of the trigeminal nerve. These episodic bouts of severe facial pain can last seconds to minutes, occur several times per day, and often result in significant disability. The neuropeptide calcitonin gene-related peptide (CGRP) is thought to play an important role in the development of neuronal sensitization and neuropathic pain and its aberrant release from the trigeminal nerve has been implicated in the pathophysiology of trigeminal neuralgia. Rimegepant is Biohaven's lead oral, selective and potent small molecule calcitonin gene-related peptide (CGRP) receptor antagonist currently being developed for the treatment of migraine.

"CGRP is an important mechanistic target that has been implicated in a variety of diseases. Emerging evidence suggests that aberrant release of CGRP from the trigeminal ganglion plays a critical role in the development of pain syndromes such as trigeminal neuralgia," Robert Croop, M.D., Biohaven Chief Development Officer - Neurology , said. "We believe this study is the oral first CGRP receptor antagonist being studied for use as a potential treatment of trigeminal neuralgia and extends our CGRP clinical research beyond migraine."

This trial will enroll patients in a double-blind, placebo-controlled, crossover design at Johns Hopkins Medical Center. Researchers will evaluate the efficacy and safety of rimegepant in treating trigeminal neuralgia in patients who failed to respond adequately to pharmacotherapy. The primary outcome measure is the change in a patient's average Numeric Pain Rating Scale between the two treatment phases of the study.

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