Concert Pharma Completes End-of-Phase 2 Meeting With FDA For CTP-499

(RTTNews) - Concert Pharmaceuticals Inc. (CNCE) announced Tuesday that it successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration or 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 or SPA to the FDA later this year.