Dupixent Posts Positive Results in Phase III Pediatric Asthma Study
Dupixent continues to demonstrate its abilities to benefit asthma patients. In a Phase III study, the biologic met primary and all key secondary endpoints in children ages 6 to 11 who have uncontrolled moderate-to-severe asthma.
This morning, Regeneron Pharmaceuticals and Sanofi announced the study results, which they said suggest Dupixent has the potential to be a best-in-class treatment option. The study, which included a broad type 2 inflammatory asthma patient population, showed that Dupixent added to the standard of care significantly reduced asthma attacks (exacerbations) and improved lung function as early as two weeks after the first dose, compared to standard of care alone. Dupixent significantly reduced severe asthma attacks by up to 65% over one year compared to placebo, the study showed. The companies said more than 90% of the children who participated in the pivotal Phase III study had at least one concurrent type 2 inflammatory condition, including atopic dermatitis and eosinophilic esophagitis.
George Yancopoulos, president and chief scientific officer of Regeneron, said the Phase III results show the efficacy of Dupixent in treating asthma in patients with markers of type 2 inflammation. Despite the availability of corticosteroid treatments, children with moderate-to-severe asthma live with a heavy and unpredictable disease burden, Yancopoulos said. Many of these patients on standard-of-care treatment continue to suffer from asthma attacks and require hospitalization for their disease, he added.
“Children with uncontrolled moderate-to-severe asthma often struggle to breathe, largely because of their impaired lung function, and this can have a serious impact on a child's quality of life. It not only reduces their ability to participate in day-to-day activities, but can also take a huge emotional toll on the child and their family," John Reed, Global Head of Research and Development at Sanofi said in a statement. “Dupixent is the only biologic shown in a controlled Phase III trial to improve lung function in children, which is generally consistent with results seen in the adolescent and adult trials. These positive data are especially encouraging for younger children who are struggling to manage their uncontrolled asthma.”
Safety results from the trial were generally consistent with the known safety profile of Dupixent in patients aged 12 years and older with moderate-to-severe asthma.
Regeneron and Sanofi intend to use the results from this study to seek additional regulatory approvals for Dupixent in this indication. Dupixent has been approved for multiple conditions with underlying type 2 inflammation.
Dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 and interleukin-13 proteins. Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), atopic dermatitis and eosinophilic esophagitis.
Last month, the two companies presented long-term data in treating asthma patients with Dupixent at the virtual 2020 European Respiratory Society (ERS) International Congress. Data showed that over the course of three years, the patients experienced improved lung function by 13-22% compared to baseline. Patients also maintained a lower rate for severe asthma attacks. When it comes to treating type 2 inflammation, the studies showed that improvements in lung function and asthma attacks were greater in those with elevated baseline blood eosinophils or fractional exhaled nitric oxide (FeNO), which are markers of type 2 inflammation. Patients showed 22-35% reductions in blood eosinophils.