US-based CoLucid Pharmaceuticals has initiated the first Phase III trial (SAMURAI) of its lead product candidate, lasmiditan, for the acute treatment of migraine headaches in adults.
Lasmiditan is designed to deliver efficacy for the acute treatment of migraine headaches in adults without the vasoconstrictor activity associated with previous generations of migraine therapies.
SAMURAI is designed to evaluate the safety and efficacy of lasmiditan 100mg and 200mg in comparison to placebo two hours after dosing on freedom from migraine headache pain, which is the primary endpoint, and on freedom from the most bothersome associated symptom of migraine, which is the secondary endpoint.
A total of 1,483 migraine patients will be treated with lasmiditan in the randomised, double-blind, placebo-controlled parallel group trial at around 70 US sites for about 12 months.
The company expects to include patients with migraine and those who also have cardiovascular risk factors or cardiovascular disease.
The Phase III trial is being conducted under a Special Protocol Assessment agreement with the US Food and Drug Administration (FDA).
Lasmiditan selectively targets 5-HT1F receptors expressed in the trigeminal pathway and it has been given the generic stem name 'ditan', which distinguishes it from other drug classes, including triptans, the current standard of care for migraine.
The company has already completed seven clinical trial for lasmiditan, including a thorough QTc study and a Phase IIb trial evaluating lasmiditan as a treatment for a single migraine attack in 391 patients.
Lasmiditan is designed for patients who are poorly served by the existing therapies, including patients with cardiovascular risk factors or cardiovascular disease who may not be able to take triptans.