CYT003: Phase IIb discontinued

Cytos discontinued a double-blind, international Phase IIb trial in about 360 patients with moderate to severe allergic asthma not sufficiently controlled on standard controller therapy after top-line data showed that all 3 dose levels of subcutaneous CYT003 missed the primary endpoint of improving ACQ score from baseline to week 12 vs. placebo. Cytos said patients in the placebo arm and in all CYT003 arms achieved a "clinically relevant" improvement in ACQ score. CYT003 also did not show a significant improvement over placebo in all additional endpoints, including lung function. Patients received subcutaneous CYT003 or placebo 7 times over 10 weeks. Based on the data, Cytos decided to discontinue and unblind the trial instead of continuing with a planned 9-month, blinded observation period. Additional data will be presented at the American Thoracic Society meeting in San Diego in May. ...