Sanofi & Regeneron’s asthma biologic performs well in trial
Regeneron and Sanofi have showed positive new data from a late-stage trial investigating biologic Dupilumab in adults and adolescents 12 years and over who have severe, steroid-dependent asthma.
According to results of the Liberty Asthma Venture study, adding Dupilumab to the standard therapies resulted in a strong change to the use of maintenance oral corticosteroids (OCS) by 70%, on average, compared to 42% with placebo.
Dupilumab also significantly reduced OCS use by 80%, on average, compared to 43% for placebo, in patients with baseline eosinophil counts greater than or equal to 300 cells per microliter.
At 24 weeks, despite the reduced use of OCS compared to placebo, patients taking the drug had 59% fewer attacks in the overall population and 71% fewer attacks in patients with eosinophil counts greater than or equal to 300 cells per microliter, the firms noted.
“This Phase III study showed that most severe asthma patients could substantially reduce their dependence on oral corticosteroids, with half completely eliminating their use of oral corticosteroids, which are not recommended for long-term use and can carry significant and potentially irreversible safety risks,” said George Yancopoulos, President and Chief Scientific Officer of Regeneron, commenting on the results.
“Importantly, despite a reduction in oral corticosteroid use, Dupilumab was associated with an improvement in lung function,” he added.
“Severe, uncontrolled asthma can lead to a dependence on oral corticosteroids, with systemic steroid exposure potentially leading to serious short- and long-term adverse effects, including weight gain, diabetes, osteoporosis, glaucoma, anxiety, depression, cardiovascular disease and immunosuppression,” said Professor Mario Castro, Washington University School of Medicine in St. Louis.
“There is an urgent need for new therapies that can decrease or eliminate chronic oral corticosteroid use, as well as reduce severe asthma attacks and improve lung function in this difficult-to-treat patient population.”
Venture is the third trial in the uncontrolled persistent asthma pivotal clinical programme and follows encouraging data reported from the Phase III QUEST study and Phase IIb pivotal study of Dupilumab.
The companies said they plan to submit a Supplemental Biologics License Application for Dupilumab, which blocks the IL-4/IL-13 pathway, a key driver of Type 2 allergic inflammation, to the US Food and Drug Administration by the end of this year.