focusing on therapies for cardinal nervous system disorders, announced Phase
II results of its tether compound COL-144 in the treatment of acute hemicrania.
Results demonstrated that COL-144 was safe and good 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 potent 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 study, the legal age of patients experienced sick headache
relief 20 to 40 minutes afterwards dosing and COL-144 was generally
well-tolerated," Alison Pilgrim, BM, BCh, DPhil, chief medical military 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 electric current standard of care."
The randomized, double blind study evaluated 130 sick headache patients.
Patients were non on prophylaxis and received 2.5 to 45 mg of COL-144 or
placebo as an intravenous infusion all over 20 minutes as first-line treatment of
an intense migraine tone-beginning. The principal end-point parameter was headache
response, defined as a reduction in headache rigor from tame to austere
at baseline to modest or no headache at two hours after foundation of infusion
of survey 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 running association
betwixt response rates and dose levels (p= 0.0126). The adaptative study blueprint
used could identify doses giving a headache reply in 50-75% of patients.
It did not explore the maximum possible efficacy of the drug.
COL-144 was generally well-tolerated with no unplayful adverse events or
withdrawals due to non-serious adverse events. The most vulgar adverse event
was paresthesia, which was usually mild and transient, resolving quickly
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.
"We identified doses of 20 mg and higher as doses of interest for further
evaluation in future studies, and we plan to persist in the clinical
development of COL-144, victimisation an unwritten formulation," added Dr. Pilgrim.
About CoLucid Pharmaceuticals, Inc.
CoLucid Pharmaceuticals was founded in December 2005 by Pappas Ventures
to bring forward innovative do drugs candidates with the potential to provide safe and
effective discourse for central nervous system (CNS) disorders. The company's
pipeline includes COL-144, a novel intervention for megrim headache, and a
conjugate stigmine platform that has generated a series of preclinical
candidates for the treatment of sleep/wake disorders, chronic nuisance,
Alzheimer's disease and psychiatrical disorders.
CoLucid Pharmaceuticals
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