Advertisement Sanofi, Regeneron announce positive Phase 2a study results of asthma drug - Pharmaceutical Business review
Pharmaceutical Business review is using cookies

ContinueLearn More
Close

Sanofi, Regeneron announce positive Phase 2a study results of asthma drug

Sanofi and Regeneron Pharmaceuticals have announced positive Phase 2a study results of dupilumab (SAR231893/REGN668) in patients with moderate-to-severe allergic asthma.

The study of the IL-4R alpha inhibitor demonstrated 87% reduction in risk of asthma exacerbations in moderate-to-severe asthma patients with elevated eosinophils.

Trial lead investigator and the University of Pittsburgh the Asthma Institute professor of medicine and director Sally Wenzel said, "These encouraging data support the potential role of IL-4/IL-13 blockade in an important subset of asthma patients and warrant continued clinical investigation."

A total of 104 patients with moderate-to-severe, persistent asthma that was not well controlled with inhaled glucocorticosteroids and long-acting beta agonist therapy, and with elevated blood or sputum eosinophils were enrolled in the proof-of-concept study.

Evaluation of the effect of dupilumab, dosed subcutaneously, each week at 30mg for twelve weeks is the primary objective.

According to the data, clinically meaningful and statistically significant improvements for lung function and other asthma control parameters, such as forced expiratory volume over one second were observed.

The most common adverse events for placebo and dupilumab were injection-site reaction, nasopharyngitis, upper respiratory tract infection, headache and nausea.

Regeneron Laboratories president and Regeneron chief scientific officer George Yancopoulos said, "These data, combined with our previously-reported positive proof-of-concept clinical results of dupilumab in atopic dermatitis, support the idea that blocking the IL-4/IL-13 pathway may be an effective mechanism to treat multiple allergic conditions."