Eli Lilly and Company has reported positive results from the Phase III SPARTAN clinical trial of lasmiditan for the acute treatment of migraines.
Lasmiditan is an investigational molecule designed to specifically target 5-HT1F receptors that are expressed in the trigeminal pathway, without the need for vasoconstrictor activity.
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The results showed that lasmiditan has met the primary endpoint with a greater proportion of patients being migraine-free, as well as the secondary endpoint with a statistically significant percentage of subjects experiencing relief from their most bothersome symptom two hours after the first dose.
These results were observed to be consistent for all the oral 50mg, 100mg and 200mg lasmiditan doses evaluated during the global, randomised, double-blind, placebo-controlled SPARTAN trial.
The trial included patients with a minimum of moderate migraine disability and an average of more than five migraine attacks per month, but not those with any cardiovascular risk factors or disease.
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Eli Lilly and Company migraine therapeutics global development leader Robert Conley said: "Lasmiditan has been designed to target receptors associated with migraine without the vasoconstrictor activity associated with some migraine therapies.
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By GlobalData"We hope these results are a significant step forward in the development of new acute migraine treatments for the millions of patients in need, including those who may be poorly served by existing therapies or those with cardiovascular disease or risk factors."
During the trial, statistically significant improvements were observed in additional secondary endpoints such as migraine pain relief and migraine disability, with dizziness, paresthesia, somnolence, fatigue, nausea and lethargy being the common adverse events.
Data from the SPARTAN trial is reported to be consistent with results from another Phase III SAMURAI trial of lasmiditan for the acute treatment of migraine.
SAMURAI findings reported last year indicated that the investigational candidate demonstrated statistical significance for both primary and secondary endpoints.
