Concert Pharmaceuticals, Inc. announced that it has completed enrollment of patients in a Phase II clinical trial evaluating CTP-499 for the treatment of diabetic kidney disease. CTP-499 is a novel, potentially first-in-class treatment for diabetic kidney disease. It is an inhibitor of multiple phosphodiesterase (PDE) isoforms and possesses broad pharmacological properties, inhibiting inflammation, oxidation and fibrosis that are believed to be relevant to the pathophysiology of diabetic kidney disease, other forms of kidney disease, and certain fibrotic indications. CTP-499 was developed using Concert’s DCE Platform® in which deuterium was incorporated at select positions of 1-((S)-5-hydroxyhexyl)-3,7-dimethylxanthine (HDX). CTP-499 was well-tolerated in Phase I clinical trials. CTP-499 is intended to slow progression of kidney damage in diabetic kidney disease and be additive to the current standard of care, which is treatment with an angiotensin converting enzyme inhibitor (ACEi) and/or an angiotensin receptor blocker (ARB). Concert expects to report top-line results from the Phase II study during the second-half of 2013.
“Diabetic kidney disease is now the nation’s leading cause of dialysis, kidney transplant, and death from kidney failure. This study focuses on a population at unusually high risk for rapid deterioration of kidney function, which urgently needs access to new therapies”
“Diabetic kidney disease is now the nation’s leading cause of dialysis, kidney transplant, and death from kidney failure. This study focuses on a population at unusually high risk for rapid deterioration of kidney function, which urgently needs access to new therapies,” said Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. “We are encouraged that our study completed enrollment in-line with our target timeframe and look forward to assessing the potential of CTP-499 to improve the long-term health of patients affected by diabetic kidney disease.”
The Phase II study is a randomized, double-blind, placebo-controlled, multi-center clinical trial designed to evaluate the safety and efficacy of CTP-499 in Type 2 diabetic patients with macroalbuminuria and estimated glomerular filtration rate between 23 and 89. There are over one million adults and children in the US with macroalbuminuria and such patients have strongly elevated risks for both progression to end-stage renal disease and mortality. The study enrolled 182 patients. Following a stabilization and screening period, patients were randomized to receive 600 mg of CTP-499 or placebo twice daily for 24 weeks. The primary endpoint of the study is the change in urine albumin to creatinine ratio (UACR), a marker of kidney damage, following treatment with CTP-499 versus the pre-treatment baseline value. Following 24 weeks, patients have the option to continue in an extension arm of the study for an additional 24 weeks.
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