Sanofi (SNYNF,SNY) and Regeneron Pharmaceuticals Inc. (REGN) announced the publication of positive Phase 2a study results of dupilumab in patients with moderate-to-severe allergic asthma. Dupilumab is a fully human monoclonal antibody and is administered via subcutaneous injection. Dupilumab was created using Regeneron's VelocImmune technology and is being co-developed with Sanofi.
The proof-of-concept study enrolled 104 patients with moderate-to-severe, persistent asthma that was not well controlled with inhaled glucocorticosteroids (ICS) and long-acting beta agonist (LABA) therapy.
The primary objective of the trial was to assess the effect of dupilumab, dosed subcutaneously, weekly at 300 milligrams for twelve weeks. Patients were treated with dupilumab or placebo on top of ICS and LABA therapy for the first four weeks of the study. The LABA was withdrawn at week four and the ICS was tapered to withdrawal between weeks six and nine.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, the primary endpoint of the study. 23 patients (44.2%) receiving placebo experienced an asthma exacerbation compared to three patients (5.8%) receiving dupilumab, resulting in an 87% reduction in the incidence of asthma exacerbations for the dupilumab arm compared to placebo.
George Yancopoulos, Chief Scientific Officer of Regeneron, 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. We look forward to initiating Phase 2b studies in both asthma and atopic dermatitis shortly."
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