No sedation or ataxia observed and treatment was well tolerated
Company plans to initiate a Phase 2 trial this year
Data presented at the American Neurological Association Annual Meeting
"We are very pleased to have completed our clinical evaluation of
CTP-354 in this Phase 1 trial. We remain on track to advance the program
into Phase 2 testing later this year, initially targeting spasticity in
patients with spinal cord injury followed by the start of a Phase 2
trial in multiple sclerosis patients in early 2015," stated
The Phase 1 multiple ascending dose clinical trial was a randomized, double-blind, placebo-controlled study in 30 healthy volunteers. The primary objective of the trial was to evaluate the safety, tolerability and pharmacokinetics of 10-day repeat dosing of 2 mg, 6 mg and 12 mg of CTP-354. Clinical highlights include:
The Company previously reported positive results from both a Phase 1 single ascending dose trial and a Phase 1 brain imaging trial as measured by positron emission tomography, or PET imaging. The long half-life and pharmacokinetic profile observed in the single ascending dose support once-daily dosing of CTP-354. In addition, CTP-354 provided high and sustained brain GABAA receptor occupancy levels in the brain imaging trial in both single and repeat doses. A copy of the poster is available online at: http://www.concertpharma.com/research/ScientificPresentations.htm
Based on the results of the Phase 1 trials, Concert intends to advance CTP-354 into Phase 2 clinical evaluation later this year. The Phase 2 program is projected to include two trials: one evaluating spasticity associated with spinal cord injury and one evaluating spasticity associated with multiple sclerosis.
CTP-354 is a novel, potentially first-in-class, non-sedating, once-daily oral treatment for spasticity. Concert is initially developing CTP-354 for use in patients with spinal cord injury and in patients with multiple sclerosis to address significant unmet medical needs. CTP-354 is a subtype-selective GABAA receptor modulator. GABAA receptors are found in the nervous system and, when activated, reduce the transmission of certain nerve signals. Several classes of widely used drugs target GABAA receptors, including benzodiazepines, but do not have the receptor subtype selectivity of CTP-354.
Spasticity is a chronic condition characterized by involuntary
tightness, stiffness or contraction of muscles that occurs in patients
who have damage to the brain and/or spinal cord. Spasticity can result
from a wide range of disorders, including multiple sclerosis, spinal
cord injury, cerebral palsy, amyotrophic lateral sclerosis, stroke and
hereditary spastic paraplegia. Symptoms can range from mild muscle
tightness to more severe symptoms, including crippling and painful
inability to move limbs that can result in disability and diminished
quality of life.
Cautionary Note on Forward Looking Statements
Any statements in this press release about our future expectations,
plans and prospects, including statements about the safety or efficacy
of CTP-354 or our plans and timelines for the clinical development of
CTP-354 and other statements containing the words "anticipate,"
"believe," "continue," "could," "estimate," "expect," "intend," "may,"
"plan," "potential," "predict," "project," "should," "target," "would,"
and similar expressions, constitute forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those indicated by such
forward-looking statements as a result of various important factors,
including: the uncertainties inherent in the initiation of future
clinical trials, availability and timing of data from ongoing and future
clinical trials and the results of such trials, whether preliminary
results from a clinical trial will be predictive of the final results of
that trial or whether results of early clinical trials will be
indicative of the results of later clinical trials, and other factors
discussed in the "Risk Factors" section of our most recent Quarterly
Report on Form 10-Q filed with the
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