Late-breaking abstract: Efficacy and safety of multiple doses of QGE031 (ligelizumab) versus omalizumab and placebo in inhibiting the allergen-induced early asthmatic response

Background The effect of QGE031, a high-affinity humanized anti-IgE antibody, was evaluated versus omalizumab (OMA) and placebo in a bronchial allergen challenge model. Methods In this phase IIa, exploratory, parallel group, double-blind, placebo controlled study, 37 subjects with mild atopic asthma were randomized to three s.c. doses (240mg; N=8, 72mg; N=8 and 24mg; N=8) of QGE031 every two weeks, OMA (N=6; dosed as per dosing table) or placebo (N=7). The study was powered for a 0.05 significance level. Outcome measures were change from baseline in the concentration of inhaled allergen leading to a 15% decline in FEV1 (PC15FEV1) at 12 weeks, pharmacodynamics, safety and tolerability. Results At week 12, the change in PC15FEV1 was ∼ 3 fold higher with 72mg and 240mg QGE031 compared to OMA (Table). The change in PC15FEV1 was dose-dependent against both placebo and OMA, with 24mg QGE031 showing a smaller effect whilst 72mg and 240mg showed a similar effect size. QGE031 elicited dose and time-dependent suppression of free IgE, basophil Fc∈RI, surface IgE expression and skin prick test responses. QGE031 was well tolerated at all dose levels. View this table: Table: PC15FEV1 for QGE031 versus placebo and omalizumab at 12 weeks Conclusion QGE031 240 and 72mg demonstrated greater improvement in bronchial provocation testing compared to placebo, and both doses showed a trend for improvement compared with OMA.