The privately held biopharmaceutical company CoLucid Pharmaceuticals, Inc., have announced that is has received the clearance from the FDA, Food and Drink Administration, that it needs to proceed with the clinical studies of Lasmiditan, which was formerly known as COL-144.
Lasmiditan is an oral tablet formulation of an NAAMA, a Neurologically Acting Anti Migraine Agent, that is designed to help migraine sufferers without the need for vasoconstrictor activity that has long been associated with with previous migraine therapies.
Lasmiditan belongs to a class of chemicals known as ditans which, unlike the triptans that targeted the vasoconstrictor 5-HT1B receptors, actually penetrate the central nervous system and selectively target the 5-HT1F receptors that are expressed withing the trigeminal nerve pathway.
Five clinical studies have been successfully completed outside of the U.S., including a Phase 2b double blind placebo controlled dose ranging study treating a single migraine attack which was completed in 2010. In the Phase 2b study, lasmiditan achieved its primary endpoint of reducing a moderate or severe headache at baseline to mild or none 2 hours after dosing (p<0.0001) in 391 patients.
Differentiation of individual doses from placebo was seen as early as 30 minutes after dosing. Lasmiditan also achieved numerous secondary endpoints per other migraine symptoms such as nausea, photophobia and phonophobia. Importantly, lasmiditan’s side effect profile is highly differentiated from triptans and ergotamines, and there was no evidence of drug-related cardiovascular effects or chest symptoms in the previous five clinical studies.
“The migraine market, estimated at 30 million sufferers in the US, is an under-served market. No new class of therapies has been introduced for the treatment of acute migraine since the triptan class, which was first launched almost 20 years ago,” remarked Thomas P. Mathers, Chief Executive Officer of CoLucid. ”Patient and physician feedback note that only a portion of migraine patients are adequately controlled on triptans, and patients would welcome a new product that could offer a rapid speed of onset, superior pain relief and/or a lack of cardiovascular side effects as compared to currently available products. In addition, due to their vasoconstrictor activity, triptans are contraindicated in patients with cardiovascular disease.
Many neurologists and primary care physicians feel uncomfortable prescribing triptans because of their potential cardiovascular side effects. Lasmiditan may address these unmet needs with its novel mechanism of action, and we look forward to the results of the Phase 3 trials to confirm its rapid speed of onset, superior pain relief and lack of cardiovascular side effects,” said Mr. Mathers.
The Company is speaking with potential partners and is interacting with the FDA, and plans to advance lasmiditan into Phase 3 development.