Source: Annual Congress 2010 - New treatments for asthma and COPD
Disease area: Airway diseases

Abstract

Background: MEDI-563 binds to the IL-5R_α chain that is selectively expressed on eosinophils and basophils. Previously, single intravenous doses of MEDI-563 have depleted blood eosinophils in humans for at least 84 days at doses ≥0.3 mg/kg.
Aims and Objectives: To evaluate the safety and tolerability profiles of multiple doses of SC administered MEDI-563 in adult asthmatics.
Methods: Subjects received 3 monthly SC injections of MEDI-563 (25 [n=7], 100 [n=6], or 200 mg [n=6]) or placebo (n=6) on days 0, 28, and 56.
Results: No treatment-related serious adverse events (AEs) or study discontinuations due to AEs were reported. The two most frequent AEs (active:placebo) were upper respiratory tract infections (3/19:1/6) and asthma exacerbations (3/19:0/6). The placebo group had a higher baseline median FEV₁ value than the combined MEDI-563 cohorts (91% [range, 80%-117%] vs 73% [range, 58%-89%]). Median peripheral blood eosinophil counts reached zero (0-10 cells/μL) in all active cohorts by day 7. The median count remained at zero (0-70 cells/μL) for at least 161 days in all dosing cohorts except for an outlier (560 cells/μL) at day 112 in the 25-mg cohort.
Conclusions: In this phase 2 study, MEDI-563 exhibited an acceptable safety profile and almost completely depleted peripheral blood eosinophils within a few days of administration; this effect lasted at least 161 days in all cohorts.

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Citations should be made in the following way:
D. Gossage, G. Geba, A. Gillen, C. Le, N. Molfino (Gaithersburg, United States Of America). A multiple ascending subcutaneous (SC) dose study of MEDI-563, a humanized anti-IL-5R_α monoclonal antibody, in adult asthmatics. Eur Respir J 2010; 36: Suppl. 54, 1177

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