CAMBRIDGE, Mass., Dec. 8, 2015 (GLOBE NEWSWIRE) -- CoLucid Pharmaceuticals, Inc. (Nasdaq:CLCD), a Phase 3 clinical-stage biopharmaceutical company that is developing its lead product candidate, lasmiditan, for the acute treatment of migraine headaches, announced today the appointment of Raymond D. Skwierczynski, Ph.D. as Head, Pharmaceutical Operations. In his capacity, Dr. Skwierczynski will be responsible for drug substance and drug product manufacturing, analytical, formulation, and both clinical trial and commercial supply chain.
Previously, Dr. Skwierczynski served as Senior Director, Pharmaceutical Technology R&D Laboratory at Takeda Pharmaceuticals (formerly Millennium Pharmaceuticals) where he led departments of scientists and engineers responsible for all aspects of small-molecule formulation and analytical development from discovery to commercialization for oral and IV routes of delivery. Dr. Skwierczynski contributed to the late-stage development of ixazomib and alseritib, where he established development and regulatory strategies for pre-clinical development through registration related to pharmaceutical operations. Prior to Takeda, Dr. Skwierczynski held positions of increasing responsibility with 3M Pharmaceuticals and Roche Carolina. Dr. Skwierczynski also serves as a member of an Expert Committee for the United States Pharmacopeia.
"We are thrilled to have Ray join our team, especially given his significant expertise and proven track record in all aspects of late-stage and commercial scale pharmaceutical operations. Ray will allow us to accelerate our pre-commercial preparation of lasmiditan oral tablets as well as IV lasmiditan," commented Thomas P. Mathers, Chief Executive Officer of CoLucid.
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 currently enrolling patients in SAMURAI, its first of two pivotal Phase 3 clinical trials. The objective of SAMURAI is to evaluate the safety and efficacy of lasmiditan (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. SAMURAI is a randomized, double-blind, placebo-controlled parallel group study. The study is expected to treat a single migraine in up to 1,483 migraine patients with lasmiditan at approximately 80 U.S. sites. CoLucid expects patients will include those with migraine who also have cardiovascular risk factors or cardiovascular disease. SAMURAI is being conducted under a Special Protocol agreement with the U.S. Food and Drug Administration. Lasmiditan is designed to address major unmet medical needs in patients who are poorly served by currently available therapies, including patients with cardiovascular risk factors or cardiovascular disease that may not be able to take triptans.
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 clinical trial enrollment goals and the initiation of future clinical trials. Actual enrollment results 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 our 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) 915-2568