Concert Pharmaceuticals Announces Initiation of New Open Label Trial to Evaluate Once-Daily vs. Twice-Daily Dosing of CTP-543...
16 Mayo 2019 - 6:00AM
Business Wire
Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced
that it has initiated a second open label clinical trial to
evaluate once-daily compared to twice-daily oral dosing of CTP-543
in patients with alopecia areata. Patients in the trial will be
randomized to receive either 12 mg twice-daily or 24 mg once-daily
of CTP-543 over a 24 week treatment period.
This new dose regimen trial is designed to complement the first
open label trial initiated by Concert in March 2019, which is
ongoing in patients randomized to receive either 8 mg twice-daily
or 16 mg once-daily of CTP-543 over a 24 week treatment period.
These two trials are designed to inform on the optimal dosing
regimen for CTP-543 for future clinical trials.
“Our aim is to optimize the dosing regimen for CTP-543, so that
we can best meet the needs of patients with this autoimmune disease
for which there are currently no FDA-approved treatments,” said
James V. Cassella, Ph.D., Chief Development Officer of Concert
Pharmaceuticals. “We are pleased that our CTP-543 clinical efforts
are helping to lead the way to develop a new treatment for alopecia
areata.”
The open label trial will enroll approximately 60 patients with
moderate-to-severe alopecia areata in the United States and Canada.
The trial will measure the relative change in Severity
of Alopecia Tool (SALT) score between Week 24 and
baseline. The trial is expected to be completed in the first half
of 2020. All patients who complete 24 weeks of treatment will be
eligible to enroll into an open label extension study of CTP-543.
Additional information about the trial (NCT03941548) is available
on www.clinicaltrials.gov.
About CTP-543 Interim Phase 2 ResultsDuring the
late-breaking clinical trials session at the American Academy of
Dermatology (AAD) Annual Meeting on March 2, 2019, the Company
presented interim results from an ongoing Phase 2 trial. At 24
weeks, patients treated with an 8 mg twice-daily dose of CTP-543
met the primary efficacy endpoint with a statistically significant
difference compared to placebo (p <0.001). The primary outcome
measure was the proportion of patients with a ≥ 50% relative
reduction in their overall SALT score between Week 24 and baseline.
As reported, CTP-543 was generally well tolerated and there were no
serious adverse events reported. Dosing in an additional cohort
receiving a 12 mg twice-daily dose of CTP-543 compared to placebo
in the Phase 2 trial is currently ongoing. Additional information
about the CTP-543 Phase 2 results is available in the Scientific
Presentations section of Company’s website.
About CTP-543CTP-543 was discovered by applying Concert's
deuterium chemistry technology to modify ruxolitinib, a drug which
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. 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.
About Alopecia AreataAlopecia 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 with the majority of
patients initially having symptoms by age 40. It is believed to
equally affect 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 FDA for the treatment of alopecia areata.
Following the FDA’s 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 ConcertConcert 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’s pipeline of innovative medicines targets
autoimmune 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 StatementsAny
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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Justine Koenigsberg (investors)Concert Pharmaceuticals,
Inc.(781) 674-5284ir@concertpharma.comKathryn Morris (media)The
Yates Network(914) 204-6412kathryn@theyatesnetwork.com
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