Sanofi has reported positive results from two Phase III clinical trials for its Dupixent drug in adults with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
The results showed that all primary and secondary endpoints were met during both the randomised, double-blind, placebo-controlled trials named SINUS-24 and SINUS-52.
At 24 weeks, patients that received Dupixent in combination with standard of care (SOC) corticosteroid nasal spray achieved a 51% improvement in nasal congestion or obstruction severity in the SINUS-24 trial and 57% in SINUS-52, compared with 15% and 19% respectively with nasal spray alone.
In addition, the drug was observed to result in a respective 27% and 33% decrease in nasal polyps score, compared with a 4% and 7% respective increase for placebo.
Both these measures represent the co-primary endpoints of the trials.
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By GlobalDataThe drug also met secondary endpoints, including a decrease in the need for systemic corticosteroids or surgery, along with improvements in smell and chronic rhinosinusitis symptoms.
In a pre-specified group with comorbid asthma, Dupixent was found to improve lung function and asthma control.
The adverse events rates were generally similar for Dupixent and placebo arms, and investigators did not report any new or unexpected side effects.
Sanofi’s executive vice-president and research and development (R&D) global head John Reed said: “For the first time, we have Phase III data showing that a biologic can help address underlying Type 2 or allergic inflammation that causes CRSwNP. We look forward to working with regulatory authorities around the world to make Dupixent an option for people living with this chronic condition.”
being developed by Sanofi in partnership with Regeneron, Dupixent is designed to inhibit the IL-4 and IL-13 signalling pathways.
The drug has approval for the treatment of uncontrolled moderate-to-severe atopic dermatitis in adults. It is also being evaluated for diseases driven by allergic and other Type 2 inflammation, such as asthma, eosinophilic esophagitis, grass allergy and peanut allergy.
The partners intend to further assess the use of Dupixent for chronic obstructive pulmonary disease.
