Biohaven’s drug candidates are targeting areas of unmet medical needs in orphan neurologic indications and novel mechanistic approaches in the neuroscience therapeutic areas.
BHV-0223 is a novel formulation of a glutamate-modulating agent, being developed under FDA 505(b)(2) guidelines. The FDA cleared the Company’s IND for BHV-0223 in August 2015, and Biohaven has completed a pharmacokinetic study in humans and is planning to launch a pivotal bioequivalence study by 4Q2016/1Q2017 (pending delivering of commercial drug supply).
BHV-4157 is a new chemical entity (NCE) that modulates glutamate, the most abundant excitatory neurotransmitter in the human body. In May, 2016, the U.S. Food and Drug Administration (FDA) granted the company’s orphan drug designation request covering trigriluzole for the treatment of spinocerebellar ataxia (SCA). SCA is a rare, debilitating neurodegenerative disorder. Standard of care treatment is supportive and no medications are currently approved for this debilitating condition. Biohaven plans to launch enrollment in a pivot trial in SCA during Q42016/Q12017. Agents that modulate glutamate neurotransmission may also have therapeutic potential in multiple disease states involving glutamate dysfunction, including amyotrophic lateral sclerosis (“ALS”), Alzheimer’s disease, Rett syndrome, dementia, dystonia, tinnitus, anxiety disorders, affective disorders like major depressive disorder and cancers.
BHV-5000 is an in-licensed investigational agent from an undisclosed blue chip pharmaceutical company targeting NMDA receptor antagonism. Initial indications planned include an orphan neurologic disorder, post-traumatic stress disorder and treatment resistant depression.
BHV-3000 and BHV-3500 are in-licensed from an undisclosed blue chip pharmaceutical company for a neurologic indication.
Other product candidates:
Biohaven plans to advance other novel mechanistic approaches in orphan and neuroscience indications, and is actively exploring licenses for additional compounds.