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Concert Pharmaceuticals Announces
Successful End-of-Phase 2 Meeting with FDA for CTP-499
Provides Direction for Phase 3 Development in Diabetic Nephropathy
LEXINGTON, Mass.--(July 8, 2014)-- Concert Pharmaceuticals, Inc.
(NASDAQ:CNCE) today announced the successful completion of an
End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA)
for CTP-499, its investigational therapy targeting diabetic nephropathy.
During the meeting, the FDA indicated general agreement with Concert's
proposed Phase 3 development plan providing flexibility to conduct
either two clinical trials with CTP-499 or a single trial evaluating two
doses of CTP-499 compared to placebo. A reduction in the rate of
progression of renal disease, measured by a time-to-event analysis of
the composite of increases in serum creatinine (greater than or equal to
50%) or end stage renal disease, versus placebo-treated patients, was
agreed to be an acceptable Phase 3 endpoint to support the filing of a
potential New Drug Application (NDA). The Company currently plans to
submit a request for a Special Protocol Assessment (SPA) to the FDA
later this year.
"We are very pleased with the outcome of the End-of-Phase 2 meeting and
the feedback from our discussion with the FDA," stated Roger Tung,
Ph.D., President and Chief Executive Officer. "We believe the results
from the Phase 2 clinical trial of CTP-499 in diabetic nephropathy are
encouraging and appreciate the valuable guidance that the FDA has
provided us regarding the design and conduct of a Phase 3 registration
program."
About Diabetic Nephropathy
Diabetic nephropathy, or type 2 diabetic kidney disease, a condition in
which kidney function is progressively lost, can result in the need for
dialysis or kidney transplantation. It is associated with increased
morbidity and mortality, and is the leading cause of end-stage renal
disease. The current standard of care for diabetic nephropathy is
treatment with ACEis or ARBs, which are blood pressure lowering agents
that affect the renin-angiotensin system. Despite the availability of
these treatments, many patients progress to end stage renal failure and
require dialysis or kidney transplants. Approximately 40% of patients
with a history of type 2 diabetes are believed to have diabetic
nephropathy.
About CTP-499
CTP-499 is a novel, deuterium-containing, oral anti-fibrotic agent. It
is a multi-subtype selective PDE inhibitor that is being developed to
slow the progression of diabetic nephropathy in patients with
macroalbuminuria. CTP-499 is a deuterated analog of
1-(S)-5-hydroxyhexyl-3,7-dimethylxanthine, or HDX, an active metabolite
of pentoxifylline. It is being developed as an additive treatment to
angiotensin modulation with an ACEi or ARB. In April 2014, Concert
announced 48-week results of its Phase 2 clinical trial of CTP-499 in
patients with diabetic nephropathy which were presented in a
late-breaking session at the National Kidney Foundation 2014 Spring
Clinical Meeting.
About Concert
Concert Pharmaceuticals is a clinical stage biopharmaceutical company
focused on applying its DCE Platform® (deuterated chemical entity
platform) to create novel small molecule drugs. This approach starts
with approved drugs, advanced clinical candidates or previously studied
compounds that have the potential to be improved with deuterium
substitution to enhance clinical safety, tolerability and efficacy. The
Company is developing a broad pipeline targeting CNS disorders, renal
disease, inflammation and cancer.
Cautionary Note on Forward Looking Statements
Any statements in this press release about our future expectations,
plans and prospects, including statements about the potential
effectiveness of CTP-499 in treating diabetic nephropathy, our plans and
timelines for the clinical development and regulatory approval of
CTP-499 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 and other factors discussed in the "Risk Factors"
section of our Annual Report on Form 10-Q filed with the Securities and
Exchange Commission on May 14, 2014 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 trademarks of Concert Pharmaceuticals, Inc.
Contact
Investors:
Concert Pharmaceuticals, Inc.
Justine Koenigsberg, 781-674-5284
ir@concertpharma.com
or
Media:
The Yates Network
Kathryn Morris, 845-635-9828 |