Concert initiates CTP-499 Phase 1 study in patients with diabetic nephropathy

Concert Pharmaceuticals, Inc. today announced it has made significant progress advancing CTP-499, its novel anti-inflammatory, anti-oxidant, and anti-fibrotic agent for diabetic nephropathy and other forms of chronic kidney disease, into clinical development. Based on encouraging preclinical results and successful formulation assessment in healthy volunteers, Concert has initiated a Phase 1 single ascending dose study of CTP-499 in healthy volunteers. CTP-499, invented using Concert's DCE Platform™ (deuterated chemical entity platform), is a potential first-in-class treatment for chronic kidney disease, a major and growing health problem.

"We are excited about the progress of CTP-499 and its potential to treat diabetic nephropathy and, more generally, chronic kidney disease," said Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. "Chronic kidney disease is a progressive disease that has become a major medical concern associated with substantial health care costs running to tens of billions of dollars per year in the US. Preclinical evidence that CTP-499 may protect kidney function and slow disease progression is encouraging. We look forward to advancing CTP-499 in clinical testing to evaluate its benefits in the treatment of diabetic nephropathy and other forms of chronic kidney disease."

Diabetic nephropathy is associated with diabetes and is the leading cause of chronic kidney disease in the US. Current standard of care for kidney disease is treatment with blood pressure lowering agents that affect the renin-angiotensin cascade, including Angiotensin Converting Enzyme inhibitors (ACEi) and Angiotensin Receptor Blockers (ARBs). Despite the use of current treatments, many patients progress to renal failure. There is a critical need for agents with novel mechanisms that further delay or prevent the decline of kidney function.