Dupilumab meets in Phase IIa asthma trial

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and partner Sanofi (Euronext:SAN; NYSE:SNY) said once-weekly subcutaneous dupilumab met the primary endpoint of reducing the proportion of patients who experienced an asthma exacerbation through week 12 vs. placebo in a Phase IIa trial to treat moderate to severe persistent asthma (5.8% vs. 44.2%, p<0.001). The double-blind, U.S. trial enrolled 104 patients whose asthma was not well controlled with inhaled glucocorticosteroids and long-acting beta agonist (LABA) therapy and who had elevated blood or sputum eosinophil levels. Data were published in the New England Journal of Medicine and presented at the American Thoracic Society meeting in Philadelphia.

By mid-year, the partners plan to start a Phase IIb trial of dupilumab to treat moderate to severe uncontrolled asthma. Data from a Phase IIa trial of dupilumab to treat moderate to severe atopic dermatitis are also expected this year, while a Phase IIb trial is slated to start mid-year. Sanofi and Regeneron are co-developing the human mAb targeting the alpha subunit of the IL-4 receptor ( CD124) under a 2007 deal. ...