Treatment with masitinib, a selective tyrosine kinase inhibitor, significantly reduces the rate of severe asthma exacerbations in patients with severe asthma uncontrolled by oral corticosteroids, according to data from a phase 3 study.
The aim of the study was to compare the safety and efficacy of masitinib (administered orally twice daily) to placebo in patients with severe asthma already treated with oral corticosteroids (N=355). The primary end point was the number of severe asthma exacerbations over the duration of patient treatment exposure.
Results showed that the trial met its primary end point, demonstrating statistical significance across all pre-specified sensitivity analyses. The findings also showed that the effect of masitinib on severe asthma exacerbations was significant in patients with severe asthma that was uncontrolled with oral corticosteroids at a minimal dose >5mg prednisone and in those with elevated eosinophil levels (≥0.15K/uL) and not well-controlled with oral corticosteroids at a minimal daily dose >5mg prednisone.
“These clinical results are supported by a strong scientific rationale,” said Jean-Pierre Kinet, MD, Co-Chairman of the Scientific Committee of AB Science. “Indeed, masitinib is a potent and selective blocker of mast cells, and it is well established that mast cells play an important role in asthma, not only in immediate hypersensitivity and in the late inflammation phase but also in tissue remodeling of the airways”.
Additional details from the study are expected to be presented at a future medical meeting. Masitinib is also being investigated in another phase 3 trial involving patients with severe persistent asthma with elevated eosinophil levels that is uncontrolled with high-dose inhaled corticosteroids.
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