CAMBRIDGE, Mass., Nov. 30, 2015 (GLOBE NEWSWIRE) -- CoLucid Pharmaceuticals, Inc. (NASDAQ:CLCD) today announced that over 50% of the migraine patients needed to complete the Company's SAMURAI trial, the first of two pivotal Phase 3 clinical trials, have now been randomized. The objective of SAMURAI is to evaluate the efficacy of lasmiditan (100 mg and 200 mg) oral tablets in comparison to placebo two hours following dosing. The primary endpoint is freedom from migraine headache pain and the key secondary endpoint is freedom from the most bothersome associated symptom of migraine (nausea, phonophobia or photophobia).
SAMURAI is a randomized, double-blind, placebo-controlled parallel group study that is expected to randomize 2,225 migraine patients and treat a single migraine in up to 1,483 migraine patients with lasmiditan at approximately 80 U.S. sites. SAMURAI is being conducted under a Special Protocol agreement with the U.S. Food and Drug Administration.
CoLucid has now randomized over 50% of the anticipated 2,225 total migraine patients for SAMURAI, and expects to have the trial fully enrolled in the first half of 2016. At least 80% of all migraine patients currently enrolled in SAMURAI have multiple risk factors for cardiovascular disease. The average age of the migraine patients enrolled in SAMURAI is 44 years old. Cardiovascular risk increases as migraine patients grow older. Lasmiditan's non-vasoconstrictive mechanism of action may be appropriate for the acute treatment of migraine patients with cardiovascular risk as these patients may be contraindicated, or warned against utilizing currently marketed acute treatments, such as triptans and ergotamines.
"We continue to be very pleased with the rate of enrollment in SAMURAI," said Bernice Kuca, Head – Clinical and Regulatory Operations. "We are grateful to our investigators for their commitment to enrolling migraine patients who have concomitant cardiovascular risk or disease, and who are not currently satisfied with marketed acute treatments for migraine. Triptans and ergotamines are vasoconstrictive therapies, and may not be an option for many migraine patients, and even NSAIDs carry warnings and precautions related to cardiovascular concerns. We continue to believe that these underserved migraine patients may benefit from the acute treatment of their migraine attacks with lasmiditan."
Thomas P. Mathers, Chief Executive Officer, will participate in a panel discussion entitled "Underdiscovered NeuroInnovators," and provide additional commentary on SAMURAI and GLADIATOR at the 27th Annual Piper Jaffray Healthcare Conference.
|27th Piper Jaffray Healthcare Conference|
|Date:||Wednesday, December 2, 2015|
|Time:||10:00am Eastern Time|
|Location:||The New York Palace Hotel|
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. 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 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 complete CoLucid's ongoing first Phase 3 pivotal trial, SAMURAI, as well as the Company's second Phase 3 pivotal trial, scheduled to commence in the first half of 2016, will be eligible to enroll in GLADIATOR. GLADIATOR is expected to enroll up to a total of 2,580 subjects, 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 was founded in 2005 and is developing oral lasmiditan for the acute treatment of migraine headaches in adults and intravenous lasmiditan for the acute treatment of unspecified headache pain 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, the initiation of future clinical trials and anticipated cash usage. 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, 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) 285-6495 Hans Vitzthum Managing Director LifeSci Advisors, LLC. (212) 915-2568Source:CoLucid Pharmaceuticals, Inc