Biohaven Pharmaceuticals declared proceeding with its clinical investigation of BHV-5000 as intimated by the US Food and Drug Administration. Enrollment of subjects has begun for the IND opening study, which will test single and multiple doses of a solid-dose formulation of BHV-5000 in healthy volunteers. BHV-5000 is being curated as a significant treatment for Rett syndrome including breathing irregularities along with plans to signal future indications for neuropathic pain and treatment-resistant depression. BHV-5000 is a low trapping, potent N-methyl-D-aspartate (NMDA) receptor antagonist licensed to Biohaven from AstraZeneca. BHV-5000 was previously advanced into a Phase 1 clinical trial, as a drug in solution formulation, and the active metabolite of BHV-5000, lanicemine, was previously advanced through Phase 2 trials.
Vlad Coric, M.D., CEO of Biohaven, said “Currently there are no approved drugs for this severe neurodevelopmental disorder. Advancement of the clinical investigation of BHV-5000 supports Biohaven’s global development strategy of providing improved therapies for patients suffering from some of the most disabling neurologic disorders.”