A new asthma drug developed by Sanofi and Regeneron, dupilumab, has met its primary objectives to demonstrate its efficacy.
Dupilumab, a treatment for uncontrolled, persistent asthma in adult and adolescent patients has cleared a Phase III trial designed to test its efficacy. It was used alongside standard therapies and successfully met its two primary endpoints, with fewer severe asthma attacks and improved lung function observed. Sanofi and Regeneron now plan to submit a secondary BLA to the FDA by the end of the year.
Dupilumab is a monoclonal antibody that inhibits overactive interleukin-4 (IL-4) and interleukin-13 (IL-13) simultaneously. IL-4 stimulates naive helper T cells, and IL-13 is involved in several stages of B cell maturation and differentiation. Both cause Type 2 allergic inflammation, which is often associated with asthma.
During asthma, the airways become inflamed and contract in response a harmless foreign antigen. This makes it difficult to breathe and can lead to an asthma attack. Standard therapies, for example, corticosteroids tend to combat airway contraction. However, combining standard therapies with dupilumab tackles both causes of symptoms.
Differences between a normal airway, an asthmatic airway and one during an attack.
“Approximately one million U.S. adults and adolescents live with uncontrolled, persistent asthma, and continue to experience serious asthma attacks, despite taking an intensive regimen of standard therapies,” said George D. Yancopoulos, President of Regeneron. The need for new treatments that can control symptoms effectively is clear. Dupilumab has now shown its ability to do so in late-stage clinical studies.
But the field is by no means deprived, especially with its worth expected to reach €24B in 2024. GSK and Teva already have products on the market, mepolizumab and reslizumab respectively, and AstraZeneca has just completed Phase III with its own monoclonal antibody, benralizumab. AstraZeneca also teamed up with Ethris to look at mRNA technology for the treatment of respiratory diseases.
The potential of dupilumab does not stop with asthma. There were positive Phase III results for the treatment of atopic dermatitis too, and further clinical trials for nasal polyps and eosinophilic esophagitis are underway. The IL-4/IL-13 pathway, targeted by dupilumab, underlies each of these. As a result, dupilumab could be used to supplement current treatments for a range of conditions.
Images – Brian A Jackson / Shutterstock.com; Health Navigator New Zealand.