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CoLucid Pharmaceuticals Provides SAMURAI Enrollment Update

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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

 

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