Phase 2 trials show Sanofi, Regeneron drug reduces risk of asthma attacks by 87%

Postive phase 2 clinical trial data of Sanofi and Regeneron's asthma treatment, dupilumab, have today been published in the New England Journal of Medicine. The study found that dupilumab (Sis AR231893/REGN668) demonstrated an 87% reduction in risk of asthma exacerbations in patients with moderate-to-severe asthma with evaluated eosinophils.

"These positive Phase 2 results are very encouraging. Dupilumab is the first monoclonal antibody that demonstrated clinically meaningful activity by blocking the IL-4R alpha subunit and consequently, both IL-4 and IL-13 signaling. These cytokines, drivers of Th2 response, are directly involved in the pathogenesis of asthma. Dupilumab significantly reduced exacerbations and daily symptoms in this study and improved pulmonary function. We are eager to move forward with the clinical development program for dupilumab."

Gianluca Pirozzi, M.D., Ph.D., Global Project Head Dupilumab, Sanofi.

The primary objective of the trial, that involved 104 patients, was to assess the effect of dupilumab, dosed subcutaneously, weekly at 300 milligrams (mg) for twelve weeks. The trial found that 23 patients (44.2%) receiving placebo experienced an asthma exacerbation compared to only 3 patients (5.8%) receiving dupilumab – an 87% reduction.

Approximately 25 million Americans have asthma and around 20% of patients are unable to control their condition, which can lead to decreased lung function, emergency room visits, and hospitalizations.