Durham-based CoLucid Pharmaceuticals, Inc. has reached an agreement with the U.S. Food and Drug Administration’s Division of Neurology Products on the strategy the young pharma will follow in developing its migraine drug candidate.

The drug, lasmiditan, is intended for patients with, or at risk of, cardiovascular disease, as well as patients who haven’t gotten help from some other treatments. Six clinical studies have been successfully completed so far, including a Phase 2b double blind placebo study where the drug achieved its primary endpoint.

Durham-based Pappas Ventures launched the company in 2005. So far, CoLucid has raised about $50 million in multiple rounds, including more than $7 million last year to fund Phase 3 trials of lasmiditan.

Durham, NC, September 18, 2012 /PRNewswire/ -- CoLucid Pharmaceuticals, Inc., a privately held biopharmaceutical company, has reached agreement with the Food and Drug Administration’s Division of Neurology Products concerning the development strategy for lasmiditan at a recently completed End of Phase 2 meeting. Lasmiditan is a novel therapy for acute migraine and will initially be developed to address major unmet needs in two patient populations who are poorly served by currently available therapies: 1) patients with risk factors for cardiovascular disease and those with diagnosed cardiovascular disease and 2) patients who have not had adequate efficacy from triptans. The development program will be confirmed via the Special Protocol Assessment process.

Lasmiditan is a first-in-class Neurally Acting Anti-Migraine Agent (NAAMA) designed to deliver efficacy in migraine without the vasoconstrictor activity associated with previous generations of migraine therapies such as triptans. Lasmiditan is a member of a novel chemical class called “ditans” and, unlike triptans, penetrates the central nervous system (CNS) and selectively targets receptors expressed in the trigeminal pathway. Lasmiditan does not interact with vasoconstrictor receptors on peripheral blood vessels which are activated by triptans.

CoLucid has further evaluated lasmiditan’s cardiovascular profile by recently completing a Thorough QT/QTc study (TQT) titled COL MIG-105: A Randomized, Double-blind, Placebo-controlled, 4-way Crossover Study to Compare the Effects on the Cardiac De- and Re-polarization Duration as well as other Cardiac Safety Parameters of Two Doses of Oral Lasmiditan (100 mg and 400 mg) with those of Moxifloxacin (400 mg) and Placebo in Healthy Subjects. The statistical evaluation of the primary variable revealed that lasmiditan caused no significant QT prolongation either at 100 mg (the putative therapeutic dose) or at 400 mg (supratherapeutic dose), whereas moxifloxacin caused a QT prolonging effect similar to that seen in published studies and thus assay sensitivity for this study was demonstrated. No pro-arrhythmic effect of lasmiditan was observed in the assessments of ECGs made by a cardiologist, and safety and tolerability were similar to observations in previous studies.

”We believe that lasmiditan’s unique central mechanism of action provides acute migraine relief without the associated chest symptoms and vasoconstrictor effects seen with triptans. Lasmiditan could be a very important treatment for those patients who are warned not to take triptans, such as patients with high blood pressure or high cholesterol, obese patients or those with diabetes, smokers and patients with a strong family history of coronary artery disease, post-menopausal women or men over 40 years of age,” commented Thomas P. Mathers, Chief Executive Officer. “There are a large number of acute migraine patients who do not respond to triptan therapy. Lasmiditan could provide an excellent therapeutic alternative for these patients who now frequently turn to opioids.”

About Lasmiditan

Six clinical studies have been successfully completed, including a Phase 2b double blind placebo controlled oral dose ranging study treating a single migraine attack. 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 secondary endpoints, including relief of nausea, photophobia and phonophobia. Importantly, because there was no evidence of drug-related cardiovascular effects or chest symptoms in the previous six clinical studies, CoLucid expects that the pivotal Phase 3 studies will confirm that lasmiditan's side effect profile is highly differentiated from triptans and ergotamines.

About CoLucid Pharmaceuticals, Inc.

CoLucid was founded in 2005 by Pappas Ventures to advance innovative drug candidates with the potential to provide safe and effective treatments for CNS disorders. The company's investors include Pappas Ventures, Domain Associates, Care Capital, Pearl Street Venture Funds and Triathlon Medical Ventures. The company's pipeline includes lasmiditan, a novel treatment for migraine headache. For more information, please visit CoLucid at www.colucid.com.