The latest CoLucid Pharmaceuticals Inc (NASDAQ:CLCD) on lasmiditan shows the outcome of a Phase 3 trial of the candidate in adult patients with acute migraine. The late-stage study dubbed SAMURAI sought to evaluate the efficacy of the candidate against a placebo in some 2,231 patients in the U.S.
SAMURAI was a randomized, double-blind study that also compared the performance of two different doses of the candidate. The drug was administered to study subjects in doses of 100mg and 200mg.
Outside efficacy, the other aspect of the SAMURAI study was to evaluate the safety profile of lasmiditan. At the end of the study, CoLucid said that lasmiditan met all primary and secondary endpoints it was pursuing in the trial.
CoLucid said the primary endpoint was freedom from migraine headache two hours after a patient received either a 100mg dose or 200mg dose of lasmiditan. Those results were benchmarked against placebo.
The secondary endpoint was freedom from symptoms such as photophobia, phonophobia and nausea, which are also called the most bothersome associated symptom of migraine (MBS), two hours after receiving a dose of lasmiditan.
Details of the study outcome
CoLucid said that 28.2% of the patients who received the 100mg dose of lasmiditan were free from migraine headache pain at two hours after receiving the treatment. But patients who received the 200mg dose fared better as 32.2% were free from migraine headache pain two after treatment. In the control arm, 15.3% of patients who received placebo registered freedom from migraine headache pain at two hours after placebo treatment.
In the secondary endpoint evaluation, 40.9% of patients who received the 100mg dose were MBS free two hours after treatment. On the 200mg dose arm, 40.7% of patients there registered freedom from MBS.
CoLucid said that lasmiditan was well tolerated across all dose levels. However, mild to moderate nervous system related treatment emergent adverse events (TEAE) were noted in patients who received lasmiditan.
Another Phase 3 study of lasmiditan
CoLucid has plans for another late-stage clinical trial of lasmiditan. The company is currently enrolling subjects to a Phase 3 long-term study dubbed GLADIATOR. CoLucid intends to submit new drug application for lasmiditan after it concludes the GLADIATOR study, which is targeting 2,580 patients.