ChemoCentryx and VFMCRP Announce Topline Data from Phase II LUMINA-1 Trial of CCX140 in Focal Segmental Glomerulosclerosis (FSGS)

MOUNTAIN VIEW, Calif. and ST GALLEN, CH, May 18, 2020 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (NASDAQ: CCXI) and Vifor Fresenius Medical Care Renal Pharma (VFMCRP) today announced topline data from a forty-six (46) patient Phase II dose-ranging trial in the orphan kidney disorder, primary Focal Segmental Glomerulosclerosis (FSGS). The LUMINA-1 trial tested CCX140, an orally-administered selective inhibitor of the chemokine receptor known as CCR2, in primary 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.

“With the CCR2 inhibitor CCX140 we desired to help people with FSGS,” said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. “Regrettably the data observed in the dose-ranging Phase II LUMINA-1 trial of CCX140 do not provide a productive way forward in this patient population. While CCX140 won’t move forward in FSGS, an entirely different situation exists with our lead program, the C5aR inhibitor avacopan. With the avacopan program, we remain intensely focused on our NDA submission for patients with ANCA-associated vasculitis mid-year, along with data readouts for the renal disease C3 glomerulopathy (C3G) by the end of the year, the dermal indication HS in Q3 and we are actively exploring the expansion of avacopan’s unique potential in kidney disease.”

Stefan Schulze, Chief Executive Officer Vifor Pharma Group comments, “Unfortunately, the results of the Phase II LUMINA-1 trial are not what we have hoped for in the interests of patients suffering from this debilitating disease. These kind of setbacks are part of clinical development activities and do not affect our confidence in our strategy and ability to deliver strong growth from new and existing products in the future. Our overall partnership and collaboration with ChemoCentryx has been highly successful and is unaffected by this development.”

LUMINA-1 was a dose-ranging Phase II 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%, and approximately 25% reduction from baseline for the geometric mean), but that did not differ significantly from the placebo group (median reduction from baseline 0.45 g/g; or approximately 22%, and approximately 23% reduction from baseline for the geometric mean). 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 (SAEs) 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.