Sanofi and Regeneron announce positive Phase 2a Results of Dupilumab in Asthma patients

21st May 2013 (Last Updated May 21st, 2013 18:30)

Dupilumab targets the alpha subunit of the interleukin 4 receptor (IL-4R alpha), which modulates signaling of both IL-4 and IL-13, drivers of Th2 (Type 2 helper T cell) immune response.

Dupilumab targets the alpha subunit of the interleukin 4 receptor (IL-4R alpha), which modulates signaling of both IL-4 and IL-13, drivers of Th2 (Type 2 helper T cell) immune response.

The University of Pittsburgh Asthma Institute director and trial lead investigator Sally Wenzel said a significant number of patients with moderate-to-severe, persistent allergic asthma are not optimally controlled, which puts them at risk of poor clinical outcomes.

"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," Wenzel said.

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

The primary objective was to assess the effect of dupilumab, dosed subcutaneously, weekly at 300mg for 12 weeks.

"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."

The study treated subjects with dupilumab or placebo on top of ICS and LABA therapy for the first four weeks. At week four, LABA was withdrawn and the ICS was tapered to withdrawal between weeks six and nine.

Patients were treated for 12 weeks or until they experienced a protocol-defined asthma exacerbation.

An 87% was noted in the reduction in the incidence of asthma exacerbations in moderate-to-severe asthma patients with elevated eosinophils for the dupilumab arm compared with a placebo.

The study also observed clinically meaningful and statistically significant improvements for lung functions and other asthma control parameters, such as forced expiratory volume over one second.

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

Regeneron Laboratories president Regeneron chief scientific officer George Yancopoulos said: "Through blockade of IL-4R alpha, dupilumab modulates signaling of both the IL-4 and IL-13 pathways, which have been implicated in the pathophysiology of Th2 mediated, or allergic, diseases such as asthma."