PRESS RELEASE
AB SCIENCE ANNOUNCES PUBLICATION IN THE JOURNAL OF ASTHMA AND ALLERGY OF POSITIVE MASITINIB PHASE 3 CLINICAL TRIAL RESULTS IN PATIENTS WITH ORAL CORTICOSTEROID-DEPENDENT SEVERE ASTHMA
This article, titled ‘Efficacy and Safety of Masitinib in Corticosteroid-Dependent Severe Asthma: A Randomized Controlled Trial’ is freely accessible online from the journal website: https://www.dovepress.com/getfile.php?fileID=81290
Study AB07015 highlights
Phase 3 study (AB07105) evaluating oral masitinib at 6 mg/kg/d versus placebo in severe asthma uncontrolled by oral corticosteroids (OCS) met its primary endpoint. Masitinib significantly decreased the rate of severe asthma exacerbations in patients with severe asthma uncontrolled by OCS.
Study AB07015 demonstrated efficacy in a difficult to treat population:
- Primary analysis was conducted in the severe asthma population with daily OCS ≥ 7.5 mg and masitinib treatment was associated with a significant reduction in severe asthma exacerbations of 35%, p=0.0103 (annualized rate adjusted for the overall time on treatment).
- A pre-specified subgroup of severe asthma patients with high eosinophil counts (≥ 150 cells/μL) also demonstrated a statistically significant reduction in rate of severe asthma exacerbations of 38%, p=0.0156 (annualized rate adjusted for the overall time on treatment).
- Benefit of masitinib was greatest in patients who had higher cumulated use of OCS (indicative of more severe asthma that is harder to control) with statistically significant reduction in rate of severe asthma exacerbations of up to 71% for patients with high eosinophil counts (≥ 150 cells/μL) receiving an annualized cumulative OCS intake of >1000 mg.
- Additional sensitivity analysis using the ERS/ATS task force recommended definition of severe exacerbations for clinical trials (i.e., an increase in stable maintenance dose of OCS for at least 3 days, wherein said increase was defined as a dose of at least 40 mg/day), showed that masitinib consistently and significantly reduced rate of severe asthma exacerbations relative to placebo across all time points tested (overall time on treatment, weeks 36, 48, 52, 72, and 96).
Study AB07015 population was distinct from other asthma trials:
- Patients were dependent on OCS (100% receiving high dose OCS therapy) and no weaning
- Patients in the primary analysis population were treated irrespective of baseline eosinophil count
- Evaluated over a long period of time (approx. 13 months)
Masitinib has a unique positioning in severe asthma, in terms of administration (oral administration), mechanism of action, targeted population, and broader eosinophil level.
References
- Davidescu L, Ursol G, Korzh O, et al. Efficacy and Safety of Masitinib in Corticosteroid-Dependent Severe Asthma: A Randomized Placebo-Controlled Trial.
Journal of Asthma and Allergy .Journal of Asthma and Allergy 2022:15 737–747. - Penn RB. Mast cells in asthma: here I am, stuck in the middle with you. Eur Respir J. 2020;56(1):2001337.
- Hinks TS, Levine SJ, Brusselle GG. Treatment options in type-2 low asthma. Eur Respir J. 2020.
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Comhair SA , et al. Mast cell phenotype, location, and activation in severe asthma. Data from the severe asthma research program. Am J Respir Crit Care Med. 2011;183(3):299–309. - Carter RJ, Bradding P. The role of mast cells in the structural alterations of the airways as a potential mechanism in the pathogenesis of severe asthma. Curr Pharm Des. 2011;17(7):685–698.
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- Maun HR, Jackman JK, Choy DF, et al. An Allosteric Anti-tryptase Antibody for the Treatment of Mast Cell-Mediated Severe Asthma Cell. 2019;179(2):417-431.e19.
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