CAMBRIDGE, Mass., June 22, 2016 (GLOBE NEWSWIRE) -- CoLucid Pharmaceuticals, Inc., (Nasdaq:CLCD) a Phase 3 clinical-stage biopharmaceutical company that is developing lasmiditan oral tablets for the acute treatment of migraine in adults, announced that it will host a Key Opinion Leader meeting on Tuesday, June 28 in New York City.
The meeting will feature a keynote presentation by Richard B. Lipton, M.D., an internationally recognized expert in headache disorders, who will discuss current and novel approaches to migraine treatment. Members of the CoLucid executive management team will provide an overview of the Company’s ongoing clinical development work with lasmiditan, a selective 5-HT1F receptor agonist, which is under development as a first-line therapy for migraine sufferers who are contraindicated from or warned against using triptans, the current standard-of-care, due to cardiovascular conditions or risk factors. CoLucid recently completed enrollment in the SAMURAI Phase III study, the first of two pivotal studies evaluating oral lasmiditan as an acute treatment for migraines.
Dr. Lipton is the Edwin S. Lowe Professor and Vice-Chair of Neurology, Professor of Epidemiology and Population Health and Professor of Psychiatry and Behavioral Sciences at Albert Einstein College of Medicine. He is also Director of the Montefiore Headache Center at Einstein. His research interests include the epidemiology and burden of episodic migraine as well as risk factors and prevention of chronic migraine. He has developed several measures widely used in clinical practice and research, including ID-Migraine, ID-Chronic Migraine, the Migraine Disability Assessment Scale (MIDAS), the Migraine Treatment Optimization Questionnaire (mTOQ), as well as the Allodynia Symptom Checklist (ASC). His work has also examined migraine genetics and biomarkers, migraine’s comorbidities as well as health-related quality of life and health economics. He was recently identified by Thompson Scientific as the most frequently referenced author of scientific publications on migraine in the world.
Dr. Lipton is Past President of the American Headache Society (AHS) and currently serves on the AHS Board and as Chair of AHS’s Chronic Migraine Education Program. He is a three time winner of the Wolff Award and recipient of the Enrico Greppi Award, all for excellence in headache research. Dr. Lipton received his medical degree from University of Chicago Pritzker School of Medicine. He completed his neurology residency and clinical neurophysiology fellowship at Einstein. He also completed a fellowship in neuroepidemiology at Columbia University.
The event is intended for investors, sell-side analysts, and business development professionals only. If you would like to attend in person, please contact Mac MacDonald at 212-915-2567 or via e-mail at Mac@LifeSciAdvisors.com to reserve a place.
A live webcast of the event, with slides, will be available at http://lifesci.rampard.com/20160628/reg.jsp and the Investors section of the Company’s website at http://investor.colucid.com/phoenix.zhtml?c=232283&p=irol-news&nyo=0.
Lasmiditan has been designed to be effective in 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 a second pivotal Phase 3 clinical trial of lasmiditan oral tablets, SPARTAN. 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 U.S., United Kingdom and Germany. CoLucid expects 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”). SPARTAN has been granted a SPA agreement with the FDA. Top-line results from SPARTAN are expected in mid-2017.
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, SPARTAN, 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 lasmiditan oral tablets 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 future clinical trials. 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) 285-6494 Hans Vitzthum Managing Director LifeSci Advisors, LLC. (212) 915-2568
Source:CoLucid Pharmaceuticals, Inc