focalisation on therapies for central nervous system disorders, announced Phase
II results of its lead compound COL-144 in the treatment of acute hemicrania.
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
causation vasoconstriction. COL-144 is a highly strong and selective 5HT1F
receptor agonist. The studies were presented in poster presentations at the
European Headache and Migraine Trust International Congress 2008 in London,
Sept. xlvii, 2008.
"In the Phase II report, 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, headman medical officeholder at
CoLucid, said. "The study indicates that COL-144 may be a handling 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 o'er 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 harshness from hold to wicked
at baseline to mild or no headache at two hours after initiation of infusion
of field of study drug.
A higher ratio of patients showed a headache answer 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 acid levels (p= 0.0126). The adaptative study design
used could identify doses giving a headache response in 50-75% of patients.
It did not explore the utmost possible efficaciousness of the drug.
COL-144 was generally well-tolerated with no good adverse events or
withdrawals due to non-serious contrary events. The most common adverse event
was paraesthesia, which was usually mild and transient, resolving speedily
after cessation of the infusion. No patient reported triptan-like bureau
symptoms in relation to the COL-144 infusion. No clinically important
changes were seen in vital signs or ECG parameters.
"We identified doses of 20 mg and higher as doses of interest for further
valuation in future studies, and we design to continue the clinical
development of COL-144, victimization an oral formulation," added Dr. Pilgrim.
About CoLucid Pharmaceuticals, Inc.
CoLucid Pharmaceuticals was founded in December 2005 by Pappas Ventures
to bring forward innovative drug candidates with the potential to supply safe and
effective discussion for fundamental nervous system (CNS) disorders. The company's
pipeline includes COL-144, a novel handling for migraine headache, and a
conjugated stigmine platform that has generated a series of preclinical
candidates for the treatment of sleep/wake disorders, chronic painfulness,
Alzheimer's disease and psychiatrical disorders.
CoLucid Pharmaceuticals
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