ST GALLEN, Switzerland & MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–Regulatory News:
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and ChemoCentryx, Inc., (NASDAQ: CCXI) 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.
Stefan Schulze, Chief Executive Officer Vifor Pharma Group said in the press release: “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.”
“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.”
Releasing topline results of study of CCX140
In an email to Pharmaceutical Daily, Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx, said that the company will release topline data from the LUMINA-2 study of CCX140.
He said that, while the results of the CCX140 LUMINA-1 dose-range finding study in 46 FSGS patients are disappointing, CCX140 will not move forward in FSGS.
He noted that the hope was to provide a new path to people with this disorder. Schall said that in the interests of advancing scientific understanding, the company will fulfill its commitment to release topline data from the LUMINA-2 study of CCX140 in patients with the more severe form of FSGS known as nephrotic syndrome, no later than the second half of 2020.
He said: “Meanwhile, as we reported earlier this month, we are on track to file by mid-2020 a New Drug Application (NDA) with the FDA for our complement 5a receptor inhibitor, avacopan, in the treatment of ANCA-associated vasculitis, following the pivotal ADVOCATE Phase III clinical trial in which avacopan demonstrated statistical superiority in sustained disease remission over the steroid-containing standard of care”.
He stressed the importance of noting that C5aR and CCR2 are two completely different biological targets; and that avacopan has a completely different mechanism of action to CCX140. “Avacopan is also in Phase II clinical trials for the treatment of Hidradenitis Suppurativa, on which we expect to report topline results in Q3, and for the rare kidney disease C3 Glomerulopathy, where we expect to announce topline data by the end of 2020.”