CoLucid Pharmaceuticals, Inc., ("CoLucid"), an innovative biotechnology company focusing on therapies for central nervous system disorders, today announced that its investigational first-in-class Neurally Acting Anti-Migraine Agent (NAAMA), lasmiditan (also known as COL-144), a selective 5-HT1F receptor agonist, was effective when given orally to treat acute migraine attacks, as documented in a Phase IIb study. Results of this study will allow the selection of doses for pivotal Phase III studies of lasmiditan in the acute treatment of migraine, scheduled to begin in fourth quarter this year.
"There is a high unmet need for novel migraine treatments that are effective and safe," said James F. White, Ph.D., President and Chief Executive Officer of CoLucid. "Currently available drugs have varying efficacy and side effects that limit their use in patients. Lasmiditan with its exciting new mechanism of action has the potential to address these patient needs."
In the recently completed double blind, randomized, placebo-controlled parallel group dose-ranging study conducted in five European countries, 391 patients treated a single migraine attack with one of four doses of lasmiditan or placebo. The Phase IIb study met its primary endpoint, showing a highly significant correlation between dose and headache relief at two hours. Individual doses showed significant benefit compared to the placebo from as early as 30 minutes after treatment. Lasmiditan also provided significant relief of other migraine symptoms, as measured in the study, including nausea, photophobia and phonophobia.
Dizziness and fatigue were the most common adverse events reported in the study. No clinically significant adverse effects were identified in either the laboratory parameters or electrocardiography (ECGs). Cardiovascular adverse events, including chest symptoms experienced with the current migraine medication group known as triptans, were rare and occurred with similar frequency in the placebo and active treatment groups.
The investigators intend to submit a complete Phase IIb data analysis for peer-review publication or presentation.
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