CAMBRIDGE, Mass.--CoLucid Pharmaceuticals, Inc., a Phase 3 clinical-stage biopharmaceutical company that is developing its lead product candidate, lasmiditan, for the acute treatment of migraine, recently announced that it has received a Special Protocol Agreement for its second pivotal Phase 3 clinical trial, called SPARTAN, from the U.S. Food and Drug Administration (FDA).
A Special Protocol Agreement is a written agreement with the FDA on the details of the design and planned analysis for a clinical trial. It is intended to form the basis for a marketing application and may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of new scientific or public health concerns before approval of an NDA. FDA’s determinations for marketing application approval are made after a complete review of the marketing application and are based on all the data in the application.
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 130 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).
“This agreement between CoLucid and the FDA for SPARTAN, our confirmatory pivotal study, provides clarity and confidence for the development pathway for lasmiditan in the U.S.,” said Thomas P. Mathers, CoLucid’s CEO. “Most importantly, our work with IMS Health has shown that the majority of migraine patients are over the age of 40 and regardless of gender, have either CAD or significant risk factors for CAD. Moreover, the use of prescription drug treatments in general, and triptans specifically, is less in these patients as compared to migraine patients without cardiovascular risk or disease. We are pleased that we will be able to enroll migraine patients with all types of concomitant cardiovascular conditions and risk factors in SPARTAN.”
Lasmiditan has been designed to deliver efficacy for the acute treatment of migraine 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. 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 who may not be able to take triptans.
CoLucid is currently enrolling patients in an additional study, 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 migraine patients enrolled in SAMURAI will include those who also have one or more cardiovascular risk factors, peripheral vascular disease or cardiovascular disease. CoLucid has now randomized over 50 percent of the migraine patients for SAMURAI, and expects to have the trial fully enrolled in the first half of 2016. At least 80 percent 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. SAMURAI is also being conducted under a Special Protocol 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 complete CoLucid’s ongoing first Phase 3 pivotal trial, SAMURAI, as well as the company’s second Phase 3 pivotal trial, SPARTAN, 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. Most (57 percent) of the patients diagnosed with migraine and receiving treatment are 40 years and older. Migraine patients have a substantially increased rate of having a cardiovascular event compared to the general population (9.9 percent compared to 6.4 percent) and 76 percent, or 2.8 million, of adult patients diagnosed with migraine have cardiovascular conditions or risk factors that contraindicate or warn against triptan use.
CoLucid is developing oral lasmiditan for the acute treatment of migraine 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.
