LONDON, Sept. 6 CoLucid Pharmaceuticals, Inc., aninnovative biotechnology company focusing on therapies for central nervoussystem disorders, announced Phase II results of its lead compound COL-144 inthe treatment of acute migraine. Results demonstrated that COL-144 was safeand effective in relieving migraine headaches. COL-144 is a first-in-classNeurally Acting Anti-Migraine Agent (NAAMA), which unlike triptans, exhibitsanti-migraine activity without causing vasoconstriction. COL-144 is a highlypotent and selective 5HT1F receptor agonist. The studies were presented inposter presentations at the European Headache and Migraine Trust InternationalCongress 2008 in London, Sept. 4-7, 2008.
"In the Phase II study, the majority of patients experienced migrainerelief 20 to 40 minutes after dosing and COL-144 was generallywell-tolerated," Alison Pilgrim, BM, BCh, DPhil, chief medical officer atCoLucid, said. "The study indicates that COL-144 may be a treatment option forall patients including those who don't respond to or are contraindicated forthe 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 orplacebo as an intravenous infusion over 20 minutes as first-line treatment ofan acute migraine attack. The primary end-point parameter was headacheresponse, defined as a reduction in headache severity from moderate to severeat baseline to mild or no headache at two hours after initiation of infusionof study drug.
A higher proportion of patients showed a headache response at two hourspost 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 associationbetween response rates and dose levels (p= 0.0126). The adaptive study designused could identify doses giving a headache response in 50-75% of patients. Itdid not explore the maximum possible efficacy of the drug.
COL-144 was generally well-tolerated with no serious adverse events orwithdrawals due to non-serious adverse events. The most common adverse eventwas paresthesia, which was usually mild and transient, resolving rapidly aftercessation of the infusion. No patient reported triptan-like chest symptoms inrelation to the COL-144 infusion. No clinically significant changes were seenin vital signs or ECG parameters.
"We identified doses of 20 mg and higher as doses of interest for furtherevaluation in future studies, and we plan to continue the clinical developmentof COL-144, using an oral formulation," added Dr. Pilgrim.
About CoLucid Pharmaceuticals, Inc.
CoLucid Pharmaceuticals was founded in December 2005 by Pappas Ventures toadvance innovative drug candidates with the potential to provide safe andeffective treatment for central nervous system (CNS) disorders. The company'spipeline includes COL-144, a novel treatment for migraine headache, and aconjugated stigmine platform that has generated a series of preclinicalcandidates for the treatment of sleep/wake disorders, chronic pain,Alzheimer's disease and psychiatric disorders. For more information, pleasevisit CoLucid at http://www.colucid.com.
SOURCE CoLucid Pharmaceuticals, Inc.