Regeneron and Sanofi have unveiled positive new data from a late-stage trial investigating the biologic dupilumab in adults and adolescents 12 years of age and older with severe, steroid dependent asthma.
According to results of the LIBERTY ASTHMA VENTURE study, adding dupilumab to standard therapies significantly cut the use of maintenance oral corticosteroids (OCS) by 70 percent on average compared to 42 percent with placebo.
Dupilumab was also shown to significantly reduce OCS use by 80 percent on average compared to 43 percent for placebo in patients with baseline eosinophil counts greater than or equal to 300 cells/microliter.
At 24 weeks, despite the reduced use of OCS, compared to placebo patients taking the drug had 59 percent fewer attacks in the overall population and 71 percent fewer attacks in patients with eosinophil counts greater than or equal to 300 cells/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.