CoLucid Pharmaceuticals Announces Initiation of Phase 3 Long-Term, Open-Label Trial of Lasmiditan in Migraine

CoLucid Pharmaceuticals, Inc.

, a Phase 3 clinical-stage biopharmaceutical company that is developing its lead product candidate, lasmiditan, for the acute treatment of migraine headaches in adults, announced today that the first patient has been randomized in the Company's GLADIATOR study, a Phase 3 long-term, open-label trial of lasmiditan. The objective of GLADIATOR is to evaluate the safety and efficacy of lasmiditan, as well as resource utilization, functional outcomes and disability. Migraine patients who complete CoLucid's ongoing first Phase 3 pivotal trial, SAMURAI, as well as the Company's second Phase 3 pivotal trial, scheduled to commence in the first half of 2016, will be eligible to enroll in GLADIATOR. GLADIATOR is expected to enroll up to a total of 2,580 subjects, who will be randomized to receive 100 mg or 200 mg of lasmiditan, and treated for up to eight migraine attacks per month for one year. Based on the results of GLADIATOR, CoLucid intends to build an appropriate safety database to support a New Drug Application ("NDA") for lasmiditan. At the time of the NDA submission, it is anticipated that there will be more than 15,000 patient exposures to lasmiditan. "We are excited by the potential of lasmiditan to become a safe and effective acute treatment for migraine headaches in adults, and are pleased with the rate of enrollment in our SAMURAI study, which is being conducted under a Special Protocol Assessment agreement with the FDA," said Thomas P. Mathers, Chief Executive Officer. "Enrollment figures for SAMURAI have confirmed our expectation that a large proportion of migraine patients have cardiovascular risk factors, and GLADIATOR will enable us to better understand the long-term safety profile of lasmiditan in these underserved migraine patients."