Concert's CTP-499 misses in diabetic nephropathy trial

Concert Pharmaceuticals Inc. (NASDAQ:CNCE) said twice-daily oral CTP-499 missed the primary endpoint of improving urine albumin-to-creatinine ratio (UACR) from baseline to week 24 vs. placebo in a Phase II trial to treat diabetic nephropathy. At week 48, patients treated with CTP-499 had a smaller increase in UACR from baseline compared to placebo (p=0.097), which Concert said may indicate stabilization of UACR in patients treated with CTP-499. The double-blind, U.S. trial enrolled 182 patients with Type II diabetic nephropathy who were receiving an angiotensin-converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB). Data were presented at the National Kidney Foundation meeting in Las Vegas.

Concert requested an end-of-Phase II meeting with FDA to discuss the development pathway for CTP-499 and potential Phase III endpoints. CTP-499 is a deuterated analog of an active metabolite of pentoxifylline, a phosphodiesterase-4 (PDE-4) inhibitor. ...