DURHAM, N.C., Aug. 18, 2011 /PRNewswire-iReach/
— Durham, NC, August 18, 2011 /PRNewswire/ — CoLucid
Pharmaceuticals, Inc., a privately held biopharmaceutical company,
announced today that it has received clearance to proceed with
clinical studies of lasmiditan (formerly known as COL-144) under
IND 103,420 from the Food and Drug Administration (FDA).
Lasmiditan is a first-in-class oral tablet formulation of a
Neurally Acting Anti-Migraine Agent (NAAMA) designed to deliver
efficacy in migraine without the vasoconstrictor activity
associated with previous generations of migraine therapies.
Lasmiditan is a member of a novel chemical class called
“ditans”, and, unlike triptans, which target vasoconstrictor 5-HT1B
receptors, lasmiditan penetrates the central nervous system (CNS)
and selectively targets 5-HT1F receptors expressed in the
trigeminal nerve pathway.
Five clinical studies have been successfully completed outside
of the U.S., including a Phase 2b double blind placebo controlled
dose ranging study treating a single migraine attack which was
completed in 2010. In the Phase 2b study, lasmiditan achieved its
primary endpoint of reducing a moderate or severe headache at
baseline to mild or none 2 hours after dosing (p<0.0001) in 391
patients. Differentiation of individual doses from placebo was seen
as early as 30 minutes after dosing. Lasmiditan also achieved
numerous secondary endpoints per other migraine symptoms such as
nausea, photophobia and phonophobia. Importantly,
lasmiditan’s side effect profile is highly differentiated from
triptans and ergotamines, and there was no evidence of drug-related
cardiovascular effects or chest symptoms in the previous five
clinical studies.
“The migraine market, estimated at 30 million sufferers in the
US, is an under-served market. No new class of therapies has
been introduced for the treatment of acute migraine since
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