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news.CoLucid Pharmaceuticals has announced positive Phase II results of its lead compound COL-144 in the treatment of acute migraine. Results demonstrated that COL-144 was safe and effective in relieving migraine headaches.
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The randomized, double-blind study evaluated 130 migraine patients. Patients were not on prophylaxis and received 2.5 to 45mg of COL-144 or placebo as an intravenous infusion over 20 minutes as first-line treatment of an acute migraine attack.
The primary end-point parameter was headache response, defined as a reduction in headache severity from moderate to severe at baseline to mild or no headache at two hours after initiation of infusion of study drug.
A higher proportion of patients showed a headache response at two hours post dose in the 10mg, 20mg, 30mg and 45mg groups compared to placebo (54.2 to 75% vs 45.2%) with a statistically significant linear association between response rates and dose levels (p= 0.0126). The adaptive study design used could identify doses giving a headache response in 50-75% of patients. It did not explore the maximum possible efficacy of the drug.
According to the company, COL-144 is a neurally acting anti-migraine agent, which unlike triptans, exhibits anti-migraine activity without causing vasoconstriction. COL-144 is a highly potent and selective 5HT1F receptor agonist.
Alison Pilgrim, chief medical officer of CoLucid, said: “The study indicates that COL-144 may be a treatment option for all patients including those who don’t respond to or are contraindicated for the current standard of care.”