For Prevention of Episodic and Chronic Migraine
BHV-3500, the second product candidate from our CGRP receptor antagonist platform, is a small molecule, structurally distinct from rimegepant, that we are developing for the prevention of chronic and episodic migraine. Chronic migraine is characterized by experiencing 15 or more headache days per month, while episodic migraine is characterized by experiencing fewer than 15 headache days per month. BHV-3500 is potent, highly soluble and selective at the human CGRP receptor. In addition, BHV-3500 has demonstrated in nonclinical studies characteristics that we believe will make it particularly well suited for daily preventative treatment of chronic and episodic migraine. Preliminary proof-of-concept has been observed in a marmoset model with oral delivery and, based on preliminary preclinical evaluations, no significant cardiovascular safety or systemic toxicity issues have been observed. We believe BHV-3500’s chemical properties also make the product candidate potentially suitable for multiple routes of delivery, including nasal, subcutaneous, inhalation or oral administration. Because BHV-3500 has exhibited an efficacy profile similar to rimegepant in preclinical studies, we believe that BHV-3500 may demonstrate similar comprehensive and durable improvements in the four key migraine symptoms.
In 2017, we plan to commence studies to enable an investigational new drug application (IND) to ultimately pursue clinical trials of BHV-3500 for the prevention of chronic and episodic migraine.