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.
In an email to Pharmaceutical Daily, Schall commented the announcement of 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.
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.”