Sanofi Posts Positive Results For Asthma Drug Dupilumab

Sanofi and its partner Regeneron Pharmaceuticals reported positive results from the Phase 2B trial of dupilumab in patients with unmanaged moderate-to-severe asthma.

Dupilumab is an investigational drug that blocks the two cytokines IL-4 and IL-13 to keep them from fulfilling their part in the Th2 (Type 2 helper T-cell) immune response. The Th2 pathway is believed to be a major player in the allergic inflammation that characterizes asthma. Sanofi and Regeneron are co-developing dupilumab as treatment for asthma, atopic dermatitis, and chronic sinusitis with nasal polyposis. Last month, the partners launched the Phase 3 study for dupilumab in atopic dermatitis.

The placebo controlled, double blind, dose ranging Phase 2B study enrolled 776 adults with moderate-to-severe unmanaged asthma. Results show that the three highest doses of dupilumab together with standard care therapy inhaled corticosteroids and long-acting beta agonist (ICS/LABA) combination products met the primary endpoint of the trial, resulting in statistically significant improvement from baseline in standard measure of lung function at Week 12 in patients with high blood eosinophils compared to placebo and standard care of therapy.

Dr. George D. Yancopoulos, CSO of Regeneron and President of Regeneron Laboratories, said, “This trial is encouraging given the positive results observed on the most clinically meaningful endpoints - FEV1, a key measure of lung function, and asthma exacerbations - were seen on top of ongoing background therapy. We look forward to continued investigation in further studies.”

Asthma is a chronic airway inflammatory disease that can be triggered by biologic or environmental factors, including dust, smoke, allergens, and viral infections, among others. When triggered, the airway narrows and mucus production is increased. Symptoms include cough, chest tightness, shortness of breath, and wheezing. An estimated 235 to 300 million people are afflicted with asthma around the world, including around 25 million in the U.S. Approximately 180,000 asthma-related deaths occur around the world annually.

“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. Based on these results, we plan to move dupilumab into Phase 3 clinical development in patients with moderate-to-severe uncontrolled asthma,” said Elias Zerhouni, President of Global R&D at Sanofi.

The Phase 2B trial for dupilumab in asthma is ongoing. Sanofi said full results from the study will be presented at a future scientific meeting.