Phase II Results of COL-144 Presented at European Headache and Migraine Trust International Congress 2008
Results Demonstrate Safety and Efficacy of First-in-Class Neurally
CoLucid Pharmaceuticals, Inc., announced 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. COL-144 is a first-in-class Neurally Acting Anti-Migraine Agent (NAAMA), which unlike triptans, exhibits anti-migraine activity without causing vasoconstriction. COL-144 is a highly potent and selective 5HT1F receptor agonist.
"In the Phase II study, the majority of patients experienced migraine relief 20 to 40 minutes after dosing and COL-144 was generally well-tolerated," Alison Pilgrim, BM, BCh, DPhil, chief medical officer at 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."
The randomized, double-blind study evaluated 130 migraine patients. Patients were not on prophylaxis and received 2.5 to 45 mg 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 10 mg, 20 mg, 30 mg and 45 mg 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.
COL-144 was generally well-tolerated with no serious adverse events or withdrawals due to non-serious adverse events. The most common adverse event was paresthesia, which was usually mild and transient, resolving rapidly after cessation of the infusion. No patient reported triptan-like chest symptoms in relation to the COL-144 infusion. No clinically significant changes were seen in vital signs or ECG parameters.
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