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CAMBRIDGE, Mass.—Migraine is the leading cause of disability among neurological disorders in the United States, according to the American Migraine Foundation. While an estimated 36 million Americans suffer from migraine—most of them women over 40—only 10 percent are diagnosed. Migraine can be extremely disabling and costly, accounting for more than an estimated $20 billion in direct and indirect expenses each year in the United States.
“Migraines are characterized by crushing headache pain, sensitivity to light, sensitivity to sound and nausea,” explained Thomas Mathers, CEO of CoLucid Pharmaceuticals. The biopharmaceutical company 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.
“At one time, people turned off the lights and sounds, tried not to throw up and tried to sleep off the migraine,” he added. “Today we use compounds to constrict the blood vessels, but that has been a problem for people with cardiovascular disease.”
Lasmiditan works inside the central nervous system, penetrating the blood-brain barrier, according to Mathers. It treats the temporal cortex and areas in the brain implicated in migraine, thus managing pain and other symptoms. It is “an easier prescribing decision, still providing relief but avoiding the cardiovascular risk of heart attack or stroke,” he said.
Designed for the acute treatment of migraine headaches in adults without the vasoconstrictor activity associated with previous generations of migraine therapies, lasmiditan 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. Results from SPARTAN are expected in the second half of 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 have completed CoLucid’s first Phase 3 pivotal trial, SAMURAI, as well as CoLucid’s second Phase 3 pivotal trial, SPARTAN, are eligible to enroll in GLADIATOR. Based on the results of GLADIATOR, CoLucid intends to build an appropriate safety database to support a New Drug Application for lasmiditan.
A key element in the migraine studies is the electronic diary (eDiary), which requires eight time-point assessments during a migraine attack. As Mathers explained, “The e-diary is very accurate, because you can never go backwards in time. Still, it requires a big commitment on the part of the participants.”
ERT, a leading provider of high-quality patient data collection solutions for use in clinical drug development, provided the electronic clinical outcome assessment (eCOA) diaries and expert solution delivery that enabled CoLucid Pharmaceuticals to achieve the primary and key secondary efficacy endpoints in its Phase 3 SAMURAI study of lasmiditan in adults with migraine. During the pivotal trial, patients used ERT’s eDiary to record migraine occurrence and to rate headache pain severity as well as presence of the most bothersome symptom. Patients then used ERT’s eDiary at protocol-defined times post-dose to assess the degree of headache pain and the presence or absence of each associated symptom.
“ERT was able to design eDiaries that were easy enough for this affected patient population to complete while suffering from migraine symptoms,” remarked Bernice Kuca, head of clinical and regulatory operations at CoLucid. “We are pleased with the implementation of the eDiary solution, which enabled us to maintain study timelines, as well as the critical endpoint data ERT delivered in support of our program.”
Ron Sullivan, executive vice president and product line executive for Ecoa, noted, “We’re honored that CoLucid relied on our eCOA system and expertise to capture this important efficacy data.”
Mathers hopes that lasmiditan will be launched in 2019. It could be a billion-dollar drug, and more importantly, he said, it could help a lot of people. “Of 4.1 million migraine sufferers, 2.2 million don’t get treated at all,” he concluded.