Concert Pharmaceuticals Provides Further Details on CTP-656 Development in U.S. and Europe
17 Enero 2017 - 6:00AM
Business Wire
Company to Host Conference Call and Webcast
Today, January 17, 2017 at 8:30 A.M. ET
Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today provided
further details on the development plan in the U.S. and Europe for
CTP-656, a next generation CFTR potentiator being developed for the
treatment of cystic fibrosis.
In the U.S., Concert initiated a placebo-controlled Phase 2
trial in December 2016 to evaluate CTP-656 in cystic fibrosis
patients with gating mutations. Subsequent to the initiation of the
study, the U.S. Food and Drug Administration (FDA) informed Concert
that, in order to support dose selection for Phase 3, an adequate
washout period, in which Kalydeco® (ivacaftor) treatment is
withheld, would be required in addition to a placebo-control. The
Company intends to further discuss the additional feedback with
FDA. The ongoing Phase 2 trial is being conducted at multiple U.S.
study sites within the Cystic Fibrosis Foundation’s Therapeutic
Development Network with topline data expected by year-end
2017.
In Europe, Concert intends to initiate an open-label Phase 2
trial in the second quarter of 2017. The trial is expected to
enroll 14 cystic fibrosis patients with gating mutations stable on
Kalydeco. Patients will be switched to one dose of CTP-656 for two
weeks followed by a switch to a higher dose of CTP-656 for an
additional two weeks. Subsequently, patients will resume treatment
with Kalydeco. The primary analysis will be for non-inferiority for
sweat chloride compared to the Kalydeco baseline. Topline data from
the European Phase 2 study of CTP-656 is expected by year-end
2017.
“We are entering a new stage in which the next wave of drug
candidates for cystic fibrosis – beyond today’s standard of care –
are advancing into later-stage clinical development. We look
forward to further discussions with FDA on the development of
CTP-656 and believe that our ongoing U.S. trial together with the
planned European study will yield data to support the progression
of CTP-656,” said Roger Tung, Ph.D., President and Chief Executive
Officer of Concert Pharmaceuticals. “We look forward to the
continued advancement of CTP-656 for both monotherapy and potential
future combination therapy.”
Conference Call and Webcast
The Company will host a conference call and webcast today
at 8:30 a.m. EST to discuss CTP-656. To access the
conference call, please dial (855) 354-1855
(U.S. and Canada) or (484) 365-2865 (International) five
minutes prior to the start time.
A live webcast of Concert's presentation may be accessed in the
Investors section of the Company's website
at www.concertpharma.com. Please log on to the Concert website
approximately 15 minutes prior to the scheduled webcast to ensure
adequate time for any software downloads that may be required. A
replay of the webcast will be available on Concert's website for
two weeks.
About CTP-656 and Cystic Fibrosis
CTP-656 is a novel CFTR potentiator that may offer next
generation, once-daily dosing and was developed by Concert’s novel
application of deuterium chemistry to modify ivacaftor. Ivacaftor
is marketed by Vertex Pharmaceuticals under the brand name
Kalydeco. Concert is initially developing CTP-656 as a potential
monotherapy treatment for cystic fibrosis due to gating mutations
of the gene that encodes for cystic fibrosis transmembrane
conductance regulator (CFTR), a protein, which regulates components
of sweat, mucus clearance and digestion. The Company also intends
to enable potentially more effective combinations to treat other
mutations, including homozygous F508del, by partnering with other
potentially complementary CFTR modulators.
Cystic fibrosis is a life-threatening, hereditary genetic
disease that has systemic effects and can cause significantly
reduced lung and digestive system function. According to the Cystic
Fibrosis Foundation, an estimated 70,000 people worldwide have
cystic fibrosis.
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 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, central nervous systems (CNS) disorders,
as well as autoimmune and inflammatory diseases. For more
information please visit www.concertpharma.com.
Cautionary Note on Forward Looking Statements
Any statements in this press release about our future
expectations, plans and prospects about the clinical development
and outcomes of CTP-656 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,
availability and timing of data from ongoing and future clinical
trials and the results of such 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, our ability to reach agreement with the
FDA regarding an adequate washout period to support dose selection
for Phase 3 and our ability to recruit patients for any such trial,
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.
Concert Pharmaceuticals Inc., the Concert
Pharmaceuticals Inc. logo and DCE Platform are registered
trademarksof Concert Pharmaceuticals, Inc.Kalydeco is a
registered trademark of Vertex Pharmaceuticals, Inc.
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version on businesswire.com: http://www.businesswire.com/news/home/20170117005339/en/
Concert Pharmaceuticals, Inc.Justine E. Koenigsberg,
781-674-5284(Investors)ir@concertpharma.comorThe Yates
NetworkBarbara Yates,
781-258-6153(Media)barbara@theyatesnetwork.com
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