Concert Pharmaceuticals Announces Plans for CTP-543 Phase 3 Trials in Alopecia Areata
01 Abril 2020 - 5:00AM
Business Wire
Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced the
details of its pivotal Phase 3 trials of CTP-543 in patients with
moderate-to-severe alopecia areata, an autoimmune disorder that
results in patchy or complete hair loss. Concert discussed key
aspects of its planned Phase 3 trials in adult patients with the
U.S. Food and Drug Administration (FDA) at a recently conducted
End-of-Phase 2 meeting. The Phase 3 program is intended to support
filing of a New Drug Application for CTP-543.
“The planned initiation of the Phase 3 program, combined with
the positive results of the Phase 2 dose ranging trial, show the
continued momentum for our development of CTP-543 for patients with
alopecia areata,” said James V. Cassella, Ph.D., Chief Development
Officer of Concert Pharmaceuticals. “Our Phase 3 clinical program
is designed to confirm the previous findings observed with CTP-543
and advance our goal to bring an important new treatment option to
people living with this life-altering autoimmune disease. Our
intent is to initiate the Phase 3 program in the fourth quarter of
2020, pending COVID-19.”
The planned Phase 3 program for CTP-543 will include two
randomized, double-blind, placebo-controlled clinical trials in
adults at sites in the U.S., Canada and Europe. The Phase 3 program
will evaluate the Severity of Alopecia Tool (SALT) score after 24
weeks of dosing in patients with moderate-to-severe alopecia
areata. Key aspects of the Phase 3 trials include:
- Patients age 18-65 years with ≥ 50% hair loss;
- Approximately 700 patients are expected to enroll in each of
the two Phase 3 trials;
- Dosing: 8 mg twice-daily or 12 mg twice-daily of CTP-543 or
placebo for 24 weeks; and
- Primary endpoint: Percent of patients achieving a SALT score
≤20 at Week 24.
The End-of-Phase 2 meeting with the FDA was requested as a
result of positive data from the dose-ranging Phase 2 trial of
CTP-543 in patients with moderate-to-severe alopecia areata.
Patients treated with either 8 mg twice-daily or 12 mg twice-daily
of CTP-543 met the primary efficacy endpoint with statistically
significant differences (p <0.001) relative to placebo in the
percentage of patients achieving a ≥ 50% relative change from
baseline at 24 weeks using SALT. The 8 mg twice-daily and 12 mg
twice-daily groups were also significantly different from placebo
in the number of patients achieving ≥ 75% and ≥ 90% relative change
in SALT from baseline at 24 weeks. At Week 24, patients treated
with 8 mg twice-daily and 12 mg twice-daily compared to placebo
also rated significantly greater improvement in their alopecia
areata on the Patient Global Impression of Improvement Scale.
Treatment with CTP-543 was generally well tolerated, with one
serious adverse event reported in the 12 mg dose group where the
patient was able to complete the trial after a brief dose
interruption.
About CTP-543 and Alopecia Areata
CTP-543 is an oral selective inhibitor of Janus kinases JAK1 and
JAK2. The FDA has granted Fast Track designation for CTP-543 for
the treatment of alopecia areata.
Alopecia areata is an autoimmune disease in which the immune
system attacks hair follicles, resulting in partial or complete
loss of hair on the scalp and body. Alopecia areata 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 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 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 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’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 Statements
Any statements in this press release about our future
expectations, plans and prospects, including, among others,
statements about our expectations regarding the design and timing
of initiation of future clinical trials for CTP-543, and any other
statements containing the words “anticipate,” “believe,”
“continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,”
“potential,” “predict,” “project,” “should,” “target,” “will,”
“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 and timing 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 Annual Report on
Form 10-K 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200401005075/en/
Justine E. Koenigsberg (Investors) Concert Pharmaceuticals, Inc.
(781) 674-5284 ir@concertpharma.com
Kathryn Morris (media) The Yates Network (914) 204-6412
kathryn@theyatesnetwork.com
Concert Pharmaceuticals (NASDAQ:CNCE)
Gráfica de Acción Histórica
De Jun 2024 a Jul 2024
Concert Pharmaceuticals (NASDAQ:CNCE)
Gráfica de Acción Histórica
De Jul 2023 a Jul 2024