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Concert Pharmaceuticals Announces
FDA Lifts Partial Clinical Hold for CTP-354, A Novel Drug Candidate for
Spasticity
LEXINGTON, Mass.--(July 16, 2014)-- Concert Pharmaceuticals, Inc.
(NASDAQ: CNCE) today announced that the FDA has provided notification
that the Company has completed the necessary preclinical toxicology
testing in order to administer repeated doses of CTP-354 in excess of 6
mg per day, lifting its partial clinical hold. As a result, the Company
intends to initiate dosing of 12 mg per day of CTP-354 in the third
quarter of this year as part of its ongoing multiple ascending dose
Phase 1 trial.
About CTP-354
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 selectively of CTP-354.
About Spasticity
Spasticity is a chronic condition characterized by involuntary
tightness, stiffness or contraction of muscles that occurs in patients
who have damage to the brain 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. The American Association of Neurologic Surgeons
estimated in 2006 that there were 12 million patients suffering from
spasticity worldwide.
About Concert
Concert Pharmaceuticals is a clinical stage biopharmaceutical company
focused on applying its DCE Platform® (deuterated chemical entity
platform) to create novel small molecule drugs. This approach starts
with approved drugs, advanced clinical candidates or previously studied
compounds that have the potential to be improved with deuterium
substitution to enhance clinical safety, tolerability and efficacy. The
company is developing a broad pipeline targeting CNS disorders, renal
disease, inflammation and cancer.
Cautionary Note on Forward Looking Statements
Any statements in this press release about our future expectations,
plans and prospects, including statements about 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 Annual
Report on Form 10-Q filed with the Securities and Exchange Commission on
May 14, 2014 and in other filings that we make with the Securities and
Exchange Commission. In addition, any forward-looking statements
included in this press release represent our views only as of the date
of this release and should not be relied upon as representing our views
as of any subsequent date. We specifically disclaim any obligation to
update any forward-looking statements included in this press release.
Concert Pharmaceuticals Inc., the CoNCERT Pharmaceuticals Inc. logo and
DCE Platform are registered trademarks of Concert Pharmaceuticals, Inc.
Contact
Concert Pharmaceuticals
Justine E. Koenigsberg (investors), 781-674-5284
ir @concertpharma.com
or
The Yates Network
Kathryn Morris (media), 845-635-9828 |