ChemoCentryx Says FDA Grants Orphan-drug Designation For CCX168 - Quick Facts

(RTTNews) - ChemoCentryx Inc. (CCXI) said that the U.S. Food and Drug Administration has granted orphan-drug designation for CCX168, an orally administered inhibitor that targets the receptor for the complement protein known as C5a (C5aR). The designation is for the treatment of anti-neutrophil cytoplasmic autoantibodies or ANCA -associated vasculitides (granulomatosis with polyangiitis or Wegener's granulomatosis, microscopic polyangiitis, and Churg-Strauss syndrome). CCX168 is currently in the third step of the CLEAR clinical trial in patients with ANCA-associated vasculitis.

The CLEAR trial is a randomized, double-blind, placebo-controlled, three-step Phase II trial being conducted at multiple study centers in Europe. The clinical trial is designed to determine whether CCX168 can partially replace or potentially eliminate full-dose corticosteroids in patients with ANCA-associated vasculitis, a desirable outcome given the toxicities of high-dose corticosteroid use. Patients are currently being enrolled in the third step of the CLEAR trial.

After meeting recently with the FDA, ChemoCentryx is currently finalizing its clinical development strategy in the U.S. More detailed information will be shared in the coming months.