Clinical-stage biopharmaceutical company ChemoCentryx has reached target enrolment of 270 patients with diabetic nephropathy in a Phase II trial designed to assess the safety, tolerability and efficacy of CCX140.
The drug candidate CCX140 is an inhibitor of the chemokine receptor known as CCR2, which is found on subsets of monocytes and macrophages and is believed to play a vital role in inflammatory processes.
The randomised, double-blind, placebo-controlled study is expecting to enrol more than 300 patients by 30 June 2013, when recruitment closes as scheduled.
ChemoCentryx president and chief executive officer Thomas Schall said the company has reached an important Phase II enrolment milestone with an over-enrolment of patients in the study.
"This achievement will enable us to report 12-week data in approximately 200 patients in the third quarter of 2013, on track with our timeline projections," Schall added.
"As our most advanced wholly owned programme, CCX140 is a key component of the ChemoCentryx pipeline targeting high-value therapeutic areas with large unmet medical needs."
Conducted at 90 sites throughout Europe, the Phase II trial will randomise the patients with either oral CCX140 at a dose of either 5mg or 10mg, or a once-daily placebo.
Initially, the efficacy of the drug on protein levels, or proteinuria, and haemoglobin A1c (HbA1c) will be evaluated in the interim analysis spanning 12 weeks.
The potential benefits of CCX140 on kidney function such as effects on serum creatinine and estimated glomerular filtration rate levels, among other measures of kidney health, will be assessed in a subsequent 52-week analysis with data expected in the third quarter of 2014.
Image: Photomicrography of nodular glomerulosclerosis in the kidney of a patient with diabetic nephropathy. Photo courtesy of CDC.