ChemoCentryx and VFMCRP Report Experimental FSGS Therapy Fails in Phase 2 Study
May 18, 2020
ChemoCentryx and Vifor Fresenius Medical Care Renal Pharma said topline data from a phase 2 dose-ranging trial of its experimental therapy CCX140 failed in a phase 2 study in patients with the rare kidney disorder primary focal segmental glomerulosclerosis.
The LUMINA-1 trial tested CCX140, an orally-administered selective inhibitor of the chemokine receptor known as CCR2, in primary focal segmental glomerulosclerosis (FSGS) subjects. In the study, CCX140 did not demonstrate a meaningful reduction in proteinuria relative to the control group after 12 weeks of blinded treatment.
FSGS is a disease that causes scar tissue to form on parts of the kidneys that filter the blood. Though secondary FSGS can be caused by a number of factors including infections, drug toxicity, and diabetes; and familial FSGS is caused by genetics, primary FSGS has no known cause.
CCX140 is an orally administered inhibitor of the chemokine receptor known as CCR2. CCX140 was previously evaluated in a phase 2 placebo-controlled, clinical trial in patients with diabetic nephropathy. CCX140 treatment in these patients resulted in a statistically significant reduction in proteinuria.
“Regrettably, the data observed in the dose-ranging phase 2 LUMINA-1 trial of CCX140 do not provide a productive way forward in this patient population,” said Thomas Schall, president and CEO of ChemoCentryx. He said the company would not move forward with CCX140 in FSGS.
LUMINA-1 was a dose-ranging phase 2 study enrolling 46 patients with primary FSGS. The primary efficacy measure was a change in proteinuria (measured by urine protein to creatinine ratio, (UPCR)) in four blinded treatment groups (three active CCX140 doses vs placebo) from baseline to week 12.
At week 12, all subjects including those in the placebo group were then treated with the highest dose of CCX140, 15 mg twice-daily (BID) for an additional 12 weeks of treatment, after which UPCR changes from week 12 to week 24 were also assessed. In the intent to treat (ITT) analysis of UPCR changes at week 12 relative to baseline, the 15 mg BID CCX140 group exhibited the greatest reduction of UPCR (median reduction from baseline 0.9 g/g or approximately 30 percent, and approximately 25 percent reduction from baseline for the geometric mean), but that did not differ significantly from the placebo group.
Also, after crossover of the blinded portion of the trial to 15 mg BID active dosing, the previous placebo group did not appear to exhibit an additional reduction of UPCR.
CCX140 at all doses was well-tolerated, with no serious adverse events during the blinded trial and a numerically lower rate of treatment-emergent adverse events in the CCX140 treatment groups than in the placebo group.
A full analysis of the LUMINA-1 data is underway and expanded results are expected to be announced at a medical meeting later this year.
Author: Rare Daily Staff
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