FDA Grants Fast Track Designation to Concert Pharmaceuticals’ CTP-543 for the Treatment of Alopecia Areata
January 12 2018 - 7:05AM
Business Wire
CTP-543 is a Novel JAK Inhibitor in Phase 2
for Alopecia Areata as Potential First-in-Class Treatment
Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced
that the U.S. Food and Drug Administration (FDA) has granted Fast
Track designation for CTP-543, a novel, oral Janus kinase (JAK)
inhibitor for the treatment of moderate-to-severe alopecia areata,
an autoimmune disorder in which the immune system attacks hair
follicles, resulting in patchy or complete hair loss.
Fast Track designation is a process designed to facilitate the
development and expedite the review of new therapies to treat
serious conditions and address unmet medical needs. With Fast Track
designation, early and frequent communications between the FDA and
the sponsor are encouraged throughout the drug development and
review process to help to ensure that questions are resolved
quickly.
“Fast Track designation recognizes that alopecia areata is a
serious disease in need of effective treatments. We look forward to
collaborating with the FDA on the development of CTP-543,” said
James Cassella, Ph.D., Chief Development Officer of Concert
Pharmaceuticals. “There are no FDA-approved treatments for alopecia
areata and CTP-543 would represent a significant medical advance as
a potential first-in-class treatment for moderate-to-severe
disease.”
Concert is conducting a multi-center, double-blind, randomized,
placebo-controlled Phase 2a trial to evaluate the safety and
efficacy of CTP-543 in adults with moderate-to-severe alopecia
areata. For additional information on the ongoing CTP-543 Phase 2a
trial, visit www.clinicaltrials.gov.
About CTP-543 and Alopecia Areata
CTP-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. Deuterium modification of ruxolitinib
was found to alter its human pharmacokinetics in ways which may
enhance its use as a treatment for alopecia areata.
The FDA selected alopecia areata as one of eight new
disease areas that it focused on under its Patient-Focused Drug
Development Initiative (PFDDI) meetings in 2016-2017. The goal of
the PFDDI is to bring patient perspectives into an earlier stage of
product development. The meeting to discuss alopecia areata was
held on Monday, September 11, 2017. Additional information is
available online at:
https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm554443.htm
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 autoimmune and inflammatory diseases and central nervous
systems (CNS) disorders. For more information please visit
www.concertpharma.com or follow us on Twitter at @ConcertPharma or
on LinkedIn.
Cautionary Note on Forward Looking Statements
Any statements in this press release about our future
expectations, plans and prospects, including statements about our
expectations for 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, availability of funding sufficient for our foreseeable
and unforeseeable operating expenses and capital expenditure
requirements 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/20180112005098/en/
Concert Pharmaceuticals, Inc.InvestorsJustine Koenigsberg,
781-674-5284ir@concertpharma.comorMediaThe Yates NetworkKathryn
Morris, 914-204-6412kathryn@theyatesnetwork.com
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