Concert Pharmaceuticals Announces Clinical Hold on CTP-543 Phase 2a Trial
May 17 2017 - 7:30AM
Business Wire
-- FDA Requested Review of Recently
Completed Non-Clinical Studies --
-- FDA Did Not Cite a Safety Concern
--
Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced
that it has received notice from the U.S. Food and Drug
Administration (FDA) that its CTP-543 Phase 2a clinical trial for
alopecia areata has been placed on clinical hold. The FDA had
previously informed the Company that it could initiate the Phase 2a
clinical trial; however, subsequent to its initiation, but prior to
dosing subjects, the FDA informed the Company that a review of
certain recently completed non-clinical toxicology studies is
required before proceeding. The FDA did not cite a safety concern;
however, they intend to review these additional non-clinical data
as support for the one-year dosing duration as planned in the Phase
2a trial.
At the request of the FDA, the Company intends to submit the
requested non-clinical study reports promptly. By regulation, the
FDA has 30 days from receipt of Concert’s response to notify the
company whether the clinical hold is lifted. Concert is working
diligently with the FDA to resume enrollment in the Phase 2a trial
as quickly as possible.
About CTP-543 and Alopecia AreataCTP-543 was discovered
by applying Concert's deuterium chemistry technology to modify
ruxolitinib, a drug which selectively inhibits Janus kinases 1 and
2 (JAK1 and JAK2) and is commercially available under the name
Jakafi in the United States for the treatment of certain
blood disorders. Ruxolitinib has been used to treat alopecia areata
in academic settings, including an investigator-sponsored clinical
trial, and has been reported to promote hair growth in individuals
with moderate-to-severe disease.
Alopecia areata is an autoimmune disease that results in partial
or complete loss of hair on the scalp and body that may affect up
to 650,000 Americans at any given time1. The scalp is the most
commonly affected area, but any hair-bearing site can be affected
alone or together with the scalp. Onset of the disease can occur
throughout life and affects both women and men. Alopecia areata can
be associated with serious psychological consequences, including
anxiety and depression. There are currently no drugs approved by
the U.S. Food and Drug Administration (FDA) for the
treatment of alopecia areata.
About ConcertConcert Pharmaceuticals is a clinical stage
biopharmaceutical company focused on applying its DCE Platform®
(deuterated chemical entity platform) to create novel medicines
designed to address unmet patient needs. The Company’s approach
starts with approved drugs in which deuterium substitution has the
potential to enhance clinical safety, tolerability or efficacy.
Concert has a broad pipeline of innovative medicines targeting
pulmonary diseases, including cystic fibrosis, autoimmune and
inflammatory diseases and central nervous systems (CNS) disorders.
For more information please visit www.concertpharma.com.
Cautionary Note on Forward Looking StatementsAny
statements in this press release about our future expectations,
plans and prospects, including statements about our expectations on
the clinical development of CTP-543, 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, 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, expectations for regulatory
approvals and other factors discussed in the "Risk Factors" section
of our most recent Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission 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.
1 Fricke M. Epidemiology and Burden of alopecia areata: a
systemic review. Clinical, Cosmetic and Investigational
Dermatology. 2015; Vol 8. 397-403.
Concert Pharmaceuticals Inc., the CoNCERT
Pharmaceuticals Inc. logo and DCE Platform are registered
trademarks of Concert Pharmaceuticals, Inc.Jakafi® is a
registered trademark of Incyte Corporation.
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version on businesswire.com: http://www.businesswire.com/news/home/20170517005242/en/
InvestorsConcert Pharmaceuticals, Inc.Justine Koenigsberg,
781-674-5284ir@concertpharma.comorMediaThe Yates NetworkKathryn
Morris, 845-635-9828kathryn@theyatesnetwork.com
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