- CoLucid Pharmaceuticals stock more than doubled in value on Tuesday after news of positive results in a Phase 3 clinical trial of its oral migraine treatment, lasmiditan.
- Lasmiditan hit both the primary and secondary endpoints in the study: A third of people with migraines were pain-free at two hours, twice as many as placebo, and over 40% were free of the "most bothersome" symptoms.
- Other studies are ongoing, including a Phase 3 study in people with or without cardiovascular risk factors, and an open-label study treating people for up to a year.
Migraine can be disabling, with direct and indirect costs of up to $20 billion each year in the U.S., according to the American Migraine Foundation (citing medical bills, missed work, and lost productivity, for example). The acute migraine market is also large, with over 36 million people in the U.S. suffering from migraine. Treatment options range from simple over-the-counter NSAIDs to prescription oral and injectable drugs.
This makes it a challenging market to enter, flooded with combinations, generics and me-toos. One potential route to success, the one taken by CoLucid, is targeting an area of unmet medical need. This could be by providing a choice for patients who have not responded to other medications, or who cannot take them because of co-morbidities.
“Most patients, regardless of gender, had either cardiovascular risk factors or cardiovascular conditions," said Thomas P. Mathers, president and chief executive officer of CoLucid. "Currently, the use of prescription drug treatments in general, and triptans specifically, is less in these patients as compared to migraine patients with no cardiovascular risk factors.”
Lasmiditan, the first in a new class of ‘ditans’, isn’t a vasoconstrictor like the market-dominating triptans, making it a potential option for patients with CV disease or other CV risk factors. CoLucid claims 76% of adult patients diagnosed with migraines also have cardiovascular conditions which warn against the use of current treatment options, such as triptans.
CoLucid stock pared back some of its gains from Tuesday in early Wednesday trading, but the stock remains over 100% higher than last Friday's close.
Top-line results from CoLucid's other pivotal Phase 3 trial of lasmiditan are expected in the second half of next year while an ongoing open-label study of the drug is aimed at building a safety database to support a NDA filing.