Positive results for Sanofi/Regeneron’s dupilumab in asthma

French pharma major Sanofi (Euronext: SAN) and US partner Regeneron Pharmaceuticals (Nasdaq: REGN) have released positive results from the interim analysis of a dose-ranging Phase IIb study of dupilumab in adult patients with uncontrolled moderate-to-severe asthma. Dupilumab is an investigational therapy blocking IL-4 and IL-13, two cytokines required for the Th2 immune response.

"Many have thought that targeting the Th2 pathway in asthma would limit benefit to a subset of asthmatics, such as those with high eosinophils. In this study, blocking IL-4/IL-13 signaling with dupilumab improved lung function and reduced severe exacerbations in the broader study population," said Elias Zerhouni, president, global R&D, at Sanofi. "Based on these results, we plan to move dupilumab into Phase III clinical development in patients with moderate-to-severe uncontrolled asthma," Dr Zerhouni added.

In the study, the three highest doses of dupilumab in combination with standard-of-care therapy met the primary endpoint of a statistically significant improvement from baseline in forced expiratory volume over one second (FEV1, a standard measure of lung function) at Week 12 in patients with high blood eosinophils (greater than or equal to 300 cells/microliter), as compared to placebo in combination with standard-of-care therapy. In addition, the two highest doses of dupilumab showed a statistically-significant improvement in mean percent change in FEV1, as well as a reduction in severe exacerbations, in both the high eosinophils and overall study population.