Wednesday, Sanofi SA ( SNY )  reported results from the Phase 2 study of oral rilzabrutinib in adult patients with uncontrolled moderate-to-severe asthma.

Two doses of rilzabrutinib, 800 mg daily and 1200 mg daily, were studied.

The data showed that treatment with oral rilzabrutinib at both high and low doses led to a numerical reduction in loss of asthma control (LOAC) events (the primary endpoint) and improvements in symptoms in adult patients with uncontrolled moderate-to-severe asthma. 

These results were presented at the 2024 American Thoracic Society (ATS) International Conference in San Diego and will support the phase 3 program, in which a twice-daily dose of rilzabrutinib will be studied for moderate-to-severe asthma.

In this proof-of-concept study, treatment with high and low doses of rilzabrutinib resulted in a 36% and 25% relative risk reduction in loss of asthma control (LOAC) events, respectively, at week 12 (primary endpoint). 

Significant and clinically meaningful improvements in asthma symptoms were also observed with a -0.54/-0.59 LS mean difference in the asthma control questionnaire.

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. 

Treatment-emergent adverse events (TEAEs) occurring with higher frequency with rilzabrutinib versus placebo were diarrhea (10.9% and 9.4% with rilzabrutinib high and low dose, versus 0% and 3.1% with matching placebo, respectively).

Recently, GSK plc ( GSK )  said headline results from the phase 3 clinical trials SWIFT-1 and SWIFT-2 of depemokimab met their primary endpoints of a reduction in the annualized rate of clinically significant exacerbations (asthma attacks) over 52 weeks versus placebo.

Price Action: SNY shares are up 1.97% at $49.92 at the last check on Wednesday.