Sanofi says results from a Phase 2 study showed treatment with oral rilzabrutinib at both high dose and low doses led to a numerical reduction in loss of asthma control events and improvements in symptoms in adult patients with uncontrolled moderate-to-severe asthma. The results will support the Phase 3 program where a twice-daily dose of rilzabrutinib will be studied for moderate-to-severe asthma, Sanofi announced. In the proof-of-concept study, treatment with high and low dose rilzabrutinib resulted in a 36% and 25% relative risk reduction in loss of asthma control events, respectively, at week 12. Nominally significant and clinically meaningful improvements in asthma symptoms were also observed. Rilzabrutinib high and low doses were well tolerated over 12 weeks of treatment with no events of cytopenia, hemorrhagic events, or atrial fibrillation and no imbalance in liver function tests, according to the company.
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