Eli Lilly’s investigational, oral, first-in-class molecule lasmiditan has hit key targets a late-stage trial assessing its safety and efficacy as a treatment for acute migraine, raising hopes for a new approach to managing the condition.
Data from the Phase III SPARTAN trial showed that at two hours following the first dose, a greater percentage of patients treated with lasmiditan were migraine pain-free compared to placebo.
Statistically significant results were observed across all three doses tested: 28.6 percent for 50mg; 31.4 percent for 100mg; 38.8 percent for 200mg and 21.3 percent for placebo.
The drug also met the key secondary endpoint across all three studied doses, with a greater percentage of patients free of their most bothersome symptom (nausea, sensitivity to sound or sensitivity to light in this study) versus placebo at two hours following the first dose.
According to Christi Shaw, president of Lilly Bio-Medicines, lasmiditan represents “the first significant innovation in the acute treatment of migraine in more than 20 years”.
The drug has been designed to target receptors associated with migraine without the vasoconstrictor activity associated with some migraine therapies, noted Robert Conley, distinguished Lilly Scholar and Lilly global development leader for migraine therapeutics.
"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."
Lilly said it intends to submit a New Drug Application for lasmiditan to the US Food and Drug Administration in the second half of 2018.