--Provides Direction for Phase 3 Development in Diabetic Nephropathy--
During the meeting, the
"We are very pleased with the outcome of the End-of-Phase 2 meeting and
the feedback from our discussion with the FDA," stated
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.
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
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
The Yates Network
News Provided by Acquire Media