Concert Pharmaceuticals, Inc. today announced the initiation of dosing in a Phase 2 clinical trial evaluating CTP-499, an investigational drug for the treatment of diabetic nephropathy, the leading cause of chronic kidney disease (CKD) in the US. CTP-499 is intended to be additive to the current standard of care, angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) therapy, to prevent or slow progression of kidney damage in diabetic nephropathy and other types of chronic kidney disease.
"Kidney disease represents a major health concern, driven by higher rates of diabetes, obesity and an aging population. Despite available treatments, many patients progress to renal failure. The current pipeline for novel treatments is limited, and there is a need for more effective pharmacologic intervention to manage CKD and to slow disease progression. CTP-499 provides a new mechanism of action that has the potential to address this substantial unmet medical need," said James Shipley, M.D., Chief Medical Officer of Concert Pharmaceuticals.
The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled, multi-center clinical trial to evaluate the safety and efficacy of CTP-499 in patients with type 2 diabetes and mild to moderate (stage 2/3) chronic kidney disease who demonstrate a loss of albumin into their urine. Such patients have an elevated risk for progression to end-stage renal disease as well as cardiovascular morbidity such as heart attack and stroke. Approximately 170 patients will be enrolled in the study. Following a stabilization period, patients will receive placebo or 600 mg of CTP-499 twice daily for 24 weeks. The primary endpoint is change in urine albumin to creatinine ratio (UACR) from pre-treatment baseline to post-treatment. Additional information about the Phase 2 clinical trial is available at www.clinicaltrials.gov.