Concert Pharmaceuticals Amends Protocol of Phase 2a Trial to Evaluate 12 mg Twice-Daily Dose Cohort of CTP-543 for the Treatm...
September 26 2018 - 7:00AM
Business Wire
Company On Track to Report Topline Data from
the 4 mg and 8 mg Twice-Daily Cohorts in Fourth Quarter of
2018
Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced
that it will include an additional cohort of patients in the Phase
2a trial evaluating CTP-543. The protocol amendment provides for
additional patients to be enrolled in the trial in order to
evaluate a 12 mg dose of CTP-543 or placebo twice daily for 24
weeks. In the third quarter of 2018, an independent Data Monitoring
Committee (DMC) conducted a planned interim safety data review
after patients in the trial had been dosed with an 8 mg dose of
CTP-543 or placebo twice daily for at least 12 weeks. Based on this
review, the DMC provided its recommendation to continue with the
current 8 mg cohort to completion and also provided support for an
additional cohort to evaluate the 12 mg dose twice daily. The
Company has initiated enrollment in the 12 mg cohort. The Company
also expects to report topline data from the 4 mg and 8 mg cohorts
of the Phase 2a trial in the fourth quarter of 2018.
“We believe that understanding a broader dose range in the Phase
2a trial will be important to our selection of the CTP-543 doses
for late stage clinical development,” stated James Cassella, Ph.D.,
Chief Development Officer of Concert Pharmaceuticals. “We are
grateful for the patient community’s support of the CTP-543
development program, as we work at the forefront of exploring new
treatment options for patients with our oral JAK inhibitor for the
treatment of alopecia areata.”
The Phase 2a trial is a double-blind, randomized,
placebo-controlled, sequential dose trial to evaluate the safety
and efficacy of CTP-543 in adult patients with moderate-to-severe
alopecia areata. With the protocol amendment, patients are
randomized to receive one of three doses of CTP-543 (4 mg, 8 mg, or
12 mg) or placebo twice daily. Enrollment in the 4 mg and 8 mg
cohorts is complete and enrollment in the 12 mg cohort is ongoing.
The primary outcome measure will utilize the severity
of alopecia tool (SALT) after 24 weeks of dosing.
Additional information about the trial is available on
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.
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 U.S. Food and Drug Administration (FDA)
has granted Fast Track designation for CTP-543.
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.
The FDA selected alopecia areata as one of eight new
disease areas that it focused on under its Patient-Focused Drug
Development Initiative (PFDDI) in 2016-2017. The goal of the PFDDI
is to bring patient perspectives into an earlier stage of product
development. Following the U.S. Food and Drug Administration’s
(FDA) Patient-Focused Drug Development meeting held in September
2017 on alopecia areata, the FDA summarized the input shared by
patients and patient representatives in a Voice of the Patient
report. Additional information on the PFDDI is available
online.
About Concert
Concert Pharmaceuticals is a clinical stage biopharmaceutical
company focused on applying its DCE Platform® (deuterated chemical
entity platform) to create novel medicines designed to treat
serious diseases and address unmet patient needs. The Company’s
approach starts with previously studied compounds, including
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 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: https://www.businesswire.com/news/home/20180926005113/en/
Investors:Concert Pharmaceuticals, Inc.Justine E. Koenigsberg
(Investors), 781-674-5284ir@concertpharma.comorMedia:The Yates
NetworkKathryn Morris, 914-204-6412kathryn@theyatesnetwork.com
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