- Comparison of 50 mg, 100 mg and 200 mg of lasmiditan oral tablets to placebo for the acute treatment of migraine
- Over 50% of the expected 2,968 migraine patients enrolled
- 77% of patients enrolled to date have multiple cardiovascular risk factors, similar to SAMURAI
- Primary and key secondary endpoints, and their powering, the same as SAMURAI
- Data expected in the second half of 2017
CAMBRIDGE, Mass., Nov. 14, 2016 (GLOBE NEWSWIRE) -- CoLucid Pharmaceuticals, Inc. (NASDAQ:CLCD) today announced that over 50% of the 2,968 migraine patients expected to enroll in the Company’s SPARTAN trial, the second of two pivotal Phase 3 clinical trials, have now been randomized. The objective of SPARTAN is to evaluate the safety and efficacy of lasmiditan (50 mg, 100 mg and 200 mg) in comparison to placebo two hours after dosing on freedom from migraine headache pain, which is the primary endpoint, and on freedom from the most bothersome associated symptom of migraine (nausea, phonophobia or photophobia), which is the key secondary endpoint.
SPARTAN is a randomized, double-blind, placebo-controlled parallel group study. The study is expected to treat a single migraine in up to 2,226 migraine patients with lasmiditan at approximately 140 sites in the United States, United Kingdom and Germany. CoLucid expects that migraine patients enrolled in SPARTAN will include those who also have one or more cardiovascular risk factors, stable cardiovascular disease or known coronary artery disease (“CAD”). Both the primary and key secondary endpoints, and their statistical powering, of SPARTAN are the same as SAMURAI, CoLucid’s recently completed first Phase 3 pivotal clinical trial. SPARTAN is being conducted under a Special Protocol Assessment (“SPA”) agreement with the U.S. Food and Drug Administration (“FDA”). Top-line results from SPARTAN are expected in the second half of 2017.
Of the migraine patients currently enrolled in SPARTAN, 85% are female, and patients range from 18 to 79 years of age, with an average age of 44. At least 77% of migraine patients enrolled in SPARTAN to date have multiple risk factors for cardiovascular disease and 3% have stable cardiovascular disease or known CAD. The patient demographics to date in SPARTAN are very similar to the demographics from SAMURAI. Lasmiditan utilizes a novel mechanism of action that is designed to not have the vasoconstrictive activity associated with some currently marketed acute migraine treatments. Lasmiditan may present a new option for the acute treatment of migraine patients with cardiovascular risk, CAD or other cardiovascular diseases as these patients may be contraindicated, or warned against utilizing currently marketed acute treatments, such as triptans and ergotamines.
“SPARTAN enrollment is tracking on schedule,” said Bernice Kuca, Head – Clinical and Regulatory Operations. “Most migraine patients that our investigators have enrolled in SPARTAN to date have concomitant cardiovascular risk or disease, as many of these patients cannot utilize marketed acute treatments for migraine. A large proportion of diagnosed migraine patients are dissatisfied with their current treatment and lasmiditan provides a new mechanism of action for the acute treatment of migraine. We continue to believe that these underserved migraine patients may benefit from the acute treatment of their migraine attacks with lasmiditan.”
Lasmiditan has been designed to deliver efficacy for the acute treatment of migraine headaches in adults without the vasoconstrictor activity associated with previous generations of migraine therapies. It selectively targets 5-HT1F receptors expressed in the trigeminal pathway of the central nervous system. Lasmiditan has been given the generic stem name “ditan,” which distinguishes it from other drug classes, including triptans, the current standard of care for migraine.
CoLucid’s first pivotal Phase 3 clinical trial of lasmiditan oral tablets, SAMURAI, was a randomized, double-blind, placebo-controlled parallel group study designed to evaluate the efficacy and safety of lasmiditan (100 mg and 200 mg) in comparison to placebo. Both the 100 mg and 200 mg doses of lasmiditan were efficacious on migraine headache pain freedom, the primary endpoint, and most bothersome associated symptom freedom, the key secondary endpoint, at the two-hour time point (p < 0.001). Both the primary and key secondary endpoints of SAMURAI conform to the FDA draft Guidance for Industry, Migraine: Developing Drugs for Acute Treatment, issued in October 2014. Both the 100 mg and 200 mg doses of lasmiditan were also more efficacious than placebo on headache pain relief at the two-hour time point (p < 0.001), as a rescue medication on headache pain freedom at the two-hour time point (p < 0.001 and p < 0.012), in reducing migraine related disability at the two-hour time point (p < 0.001) and in improving Patient Global Impression of Change (p < 0.001). Lasmiditan was well tolerated with no significant difference in cardiovascular adverse events in patients dosed with lasmiditan versus placebo. SAMURAI was conducted under a SPA agreement with the FDA.
CoLucid is also currently enrolling patients in GLADIATOR, a Phase 3 long-term, open-label trial of lasmiditan. GLADIATOR’s objective is to evaluate the safety and efficacy of lasmiditan, as well as resource utilization, functional outcomes and disability. Migraine patients who completed SAMURAI, as well as who complete SPARTAN, are eligible to enroll in GLADIATOR. GLADIATOR is expected to enroll up to a total of 2,580 patients, who will be randomized to receive 100 mg or 200 mg of lasmiditan, and treated for up to eight migraine attacks per month for one year. Based on the results of GLADIATOR, CoLucid intends to build an appropriate safety database to support a New Drug Application (“NDA”) for lasmiditan. At the time of the NDA submission, it is anticipated that there will be more than 15,000 patient exposures to lasmiditan in the entire clinical program.
Migraine is the leading cause of disability among neurological disorders in the United States according to the American Migraine Foundation. An estimated 36 million Americans suffer from migraine. Migraine can be extremely disabling and costly, accounting for more than an estimated $20 billion in direct (e.g., doctor visits, medications) and indirect (e.g., missed work, lost productivity) expenses each year in the United States.
About CoLucid Pharmaceuticals, Inc.
CoLucid is developing oral lasmiditan for the acute treatment of migraine headaches in adults and intravenous lasmiditan for the acute treatment of headache pain associated with migraine in adults in emergency room and other urgent care settings.
Certain of the statements made in this press release are forward looking, such as those, among others, relating to CoLucid’s expectations for lasmiditan’s efficacy, clinical trial enrollment goals and the timing of clinical trial results and future clinical trials, and sufficiency of cash. Actual enrollment results, use of cash and other developments may occur that differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks that enrollment goals will not be met, the patient demographics of a fully-enrolled study will differ from the demographics at any point prior thereto, trials may not be commenced or successful or may take longer to complete than anticipated, and projected cash needs and expected financial results may be different. More information about the risks and uncertainties faced by CoLucid are contained in its periodic reports filed with the Securities and Exchange Commission. CoLucid disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT Thomas Mathers Chief Executive Officer CoLucid Pharmaceuticals, Inc. (857) 285-6494 Hans Vitzthum Managing Director LifeSci Advisors, LLC. (212) 915-2568
Source:CoLucid Pharmaceuticals, Inc