Sanofi and Regeneron Pharmaceuticals said Monday that a Phase III study of dupilumab in a broad population of patients with uncontrolled, persistent asthma met its two primary endpoints. The companies indicated that they plan to seek FDA approval of the therapy in this indication by the end of this year.
In the LIBERTY ASTHMA QUEST trial, 1902 patients with uncontrolled, persistent asthma were randomised to treatment with dupilumab, administered as a dose of 200 mg every other week, with a loading dose of 400 mg, or 300 mg every other week, with a loading dose of 600 mg, or placebo. The primary endpoints of the study were the annualised rate of severe exacerbation events at 52 weeks and the absolute change from baseline in pre-bronchodilator forced expiratory volume over one second (FEV1) at 12 weeks.
Top-line results demonstrated that when added to standard therapies, dupilumab reduced severe asthma attacks and improved lung function. Data showed that at 52 weeks, in the 300 mg dose group, dupilumab reduced severe asthma attacks by 46 percent in the overall population, 60 percent in patients with 150 eosinophilic cells/microliter or greater and 67 percent in patients with 300 eosinophilic cells/microliter or greater.
Meanwhile, Sanofi and Regeneron noted that at 12 weeks, in the 300 mg dupilumab dose group, mean improvement in lung function over placebo as assessed by FEV1 was 130 mL in the overall population, 210 mL in patients with 150 eosinophilic cells/microliter or greater and 240 mL in patients with 300 eosinophilic cells/microliter or greater. The companies said that results for the 200 mg and 300 mg dupilumab dose groups were "generally comparable" on both exacerbations and FEV1.
Sanofi and Regeneron noted that additional data from the study will be submitted for presentation at a future medical meeting. The drugmakers also indicated that results from the Phase III VENTURE trial assessing the ability of dupilumab to lower oral corticosteroid use in patients with severe steroid-dependent asthma are anticipated by the end of the year.
FirstWord reports in this therapy area - KOL Insight Targeted Therapies in Asthma: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.
George Yancopoulos, chief scientific officer of Regeneron, remarked "these results continue to support our hypothesis that the IL4/IL13 pathway is a critical driver of allergic disease, and we remain committed to further investigating the IL-4/IL-13 pathway in other allergic diseases."
In March, the FDA approved dupilumab under the name Dupixent for the treatment of moderate-to-severe atopic dermatitis that is not adequately controlled with topical prescription therapies. The European Medicines Agency's Committee for Medicinal Products for Human Use backed approval of the therapy for the same indication in July. For related analysis, see ViewPoints: Brewing competition in allergy space good for all parties – except Regeneron, Sanofi.
To read more Top Story articles, click here.