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Antibody Fails Mid-Stage Study in Asthma Patients
Treatment is no better than placebo in improving pulmonary function (January 29)
Disappointing results have been reported from a randomized, double-blind, placebo-controlled phase II trial of KB003 (KaloBios Pharmaceuticals), an anti-granulocyte macrophage colony-stimulating factor (anti–GM-CSF) monoclonal antibody, in patients with severe asthma.
Although the study showed that KB003 was generally safe and well tolerated, the treatment did not meet its primary clinical endpoint of improvement in forced expiratory volume in 1 second (FEV1) — a measure of pulmonary function — compared with placebo in the overall study population.
In prespecified subgroups, eosinophilic patients (baseline blood eosinophils ≥ 0.3 GI/L) and patients demonstrating high reversibility at baseline (> 20%) showed a statistically significant improvement compared with placebo. Other subgroups, such as atopic or nonatopic patients, did not demonstrate a statistically significant improvement in FEV1 from baseline compared with placebo.
In key secondary endpoints, no meaningful reductions in exacerbations were observed in patients treated with KB003 in the overall study population or in any subgroup compared with patients given placebo. Moreover, there was no statistically significant improvement in Asthma Control Questionnaire scores in the overall patient population.
Source: KaloBios Pharmaceuticals; January 29, 2014.