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Benralizumab continuing despite Phase IIa COPD miss

September 9, 2014 2:14 AM UTC

A spokesperson for the MedImmune LLC unit of AstraZeneca plc (LSE:AZN; NYSE:AZN) told BioCentury the company started Phase III testing of benralizumab ( MEDI-563) to treat chronic obstructive pulmonary disease even after the mAb missed the primary endpoint in Phase IIa, because the earlier trial showed a significant improvement in lung function, a secondary endpoint. The primary endpoint was a reduction in acute COPD exacerbations vs. placebo in the per-protocol population and in subgroups defined by baseline concentrations of blood eosinophils.

The humanized mAb against IL-5 receptor significantly improved mean pre-bronchodilator forced expiratory volume in one second (FEV1) from baseline to week 56 vs. placebo in the per-protocol population (p=0.014). The Phase IIa data were presented at the European Respiratory Society meeting and published in The Lancet Respiratory Medicine on Monday. ...