Omalizumab meets in second Phase III for chronic idiopathic urticaria

Novartis AG (NYSE:NVS; SIX:NOVN) said subcutaneous omalizumab given every four weeks for 24 weeks as an add-on to antihistamine therapy met the primary safety endpoint in the Phase III GLACIAL trial to treat chronic idiopathic urticaria (CIU). Omalizumab also met the "key" efficacy endpoint of reducing mean weekly Itch Severity Score (ISS) score from baseline to week 12 vs. placebo (p<0.001). The double-blind, international trial enrolled 335 patients ages 12-75 with moderate to severe refractory CIU despite receiving standard of care. Data were presented at the European Academy of Allergy and Clinical Immunology-World Allergy Organization meeting in Milan.

GLACIAL is the second of three Phase III trials of omalizumab to treat CIU. In February, the partners reported data from the Phase III ASTERIA II trial, while data from the Phase III ASTERIA I trial of omalizumab are expected next half. Novartis plans to submit regulatory applications for omalizumab to treat CIU next half (see BioCentury Extra, Feb. 25). ...