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June 4, 2014

FDA grants orphan drug designation to ChemoCentryx’s CCX168

ChemoCentryx has received orphan-drug designation from the US Food and Drug Administration (FDA) for its CCX168 for treatment of anti-neutrophil cytoplasmic autoantibodies-associated vasculitides (granulomatosis with polyangiitis, microscopic polyangiitis, and Churg-Strauss syndrome).

By Mekala ShivaramPrasad

ChemoCentryx has received orphan-drug designation from the US Food and Drug Administration (FDA) for its CCX168 for the treatment of anti-neutrophil cytoplasmic autoantibodies-associated vasculitides (granulomatosis with polyangiitis, microscopic polyangiitis, and Churg-Strauss syndrome).

CCX168 is an orally administered complement C5a receptor inhibitor. Currently, CCX168 is in the third stage of the CLEAR trial in patients with anti-neutrophil cytoplasmic autoantibodies (ANCA)-associated vasculitis.

The CLEAR trial is a double-blind, three-step Phase II trial designed to determine whether CCX168 can partially replace or potentially eliminate full-dose corticosteroids in patients with ANCA-associated vasculitis.

"We believe this designation may facilitate an expeditious clinical development path for CCX168, and is emblematic of our deep commitment to supporting the community of patients with ANCA-associated vasculitis."

Patients are currently being enrolled in the third trial stage is being conducted at multiple study centres in Europe.

Following its meeting with the FDA, ChemoCentryx is currently finalising its US clinical development strategy.

ChemoCentryx president and CEO Thomas Schall said that obtaining orphan drug designation from the FDA is an important regulatory milestone for the company.

"We believe this designation may facilitate an expeditious clinical development path for CCX168, and is emblematic of our deep commitment to supporting the community of patients with ANCA-associated vasculitis," Schall said.

Results from the first two steps of the CLEAR trial demonstrated that patients receiving CCX168 showed improvements in the Birmingham Vasculitis Activity Score (BVAS).

When compared with patients receiving the standard of care, BVAS response at 12 weeks was higher in patients receiving CCX168. Both non-renal and renal disease components of BVAS were improved in patients on CCX168 treatment.

When compared with patients receiving the standard of care, patients treated with CCX168 showed greater improvements in renal function based on disease activity measurements, including estimated glomerular filtration rate, urinary albumin:creatinine ratio, and urinary monocyte chemoattractant protein-1:creatinine ratio.

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