ChemoCentryx's CCR2 inhibitor Succeeds In Phase 2 Diabetic Nephropathy Trial
By C. Rajan, contributing writer
California-based biotech company, ChemoCentryx, has announced positive results from its Phase 2 clinical trial of a novel CCR2 inhibitor, CCX140, in patients with diabetic nephropathy. The study showed that adding an oral dose of the drug, CCX140 to the standard treatment regimen resulted in a significant reduction in urinary albumin creatinine ratio (UACR), which is associated with poor renal outcomes.
The randomized, double-blind, placebo controlled Phase 2 trial enrolled 332 patients with residual albuminuria. The main objectives of the study were to determine the safety, tolerability, and clinical effects of CCX140 in patients with diabetic nephropathy. The patients were treated with a 5 mg oral dose of CCX140 daily in addition to a standard regimen of angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor II blocker (ARB) treatment.
The 52-week data showed that the investigational drug was safe, well tolerated, and effective in improving kidney function significantly in patients with diabetic nephropathy. Besides the urinary albumin protein ratio, another key parameter in assessing long-term kidney function, estimated glomerular filtration rate (eGFR), was monitored in this study. Treatment with CCX140 improved the eGFR profile sharply in the first 12 weeks and then maintained a sustained decline in eGFR.
CCX140 works by inhibiting the chemokine receptor CCR2, which is found on certain immune system cells and plays an important role in inflammatory processes. By blocking CCR2, the abnormal inflammatory response that causes renal diseases can be reduced.
"These positive data suggest that treatment with CCX140 may result in clinically meaningful improvements in kidney function when added to standard of care in patients with chronic kidney disease," said Thomas J. Schall, Ph.D., President and CEO, ChemoCentryx. "Given the positive improvements in albuminuria and eGFR observed in this clinical trial, we believe we have an effective dose of CCX140 to take forward into a Phase 3 clinical trial in diabetic nephropathy and that we are well positioned to advance partnering discussions as well as an end of Phase 2meeting with the FDA."
Diabetic nephropathy is a deadly complication in diabetic patients, which results in end-stage renal disease (ESRD), requiring dialysis or kidney transplantation. Patients with diabetic nephropathy represent about 35 percent of the overall 26 million people with chronic kidney disease.
Earlier this month, ChemoCentryx was granted Orphan Drug designation in the EU for another of its targeted receptor inhibitors, CCX168, for treating different forms of vasculitis.