Sanofi and Regeneron report positive Phase 3 results for Dupixent in children with moderate-to-severe asthma
A pivotal Phase 3 trial of Dupixent (dupilumab) met its primary and all key secondary endpoints in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma, according to press releases from Sanofi and Regeneron.
In a broad type 2 inflammatory asthma patient population, defined as having elevated eosinophils (EOS) or elevated fractional exhaled nitric oxide (FeNO), Dupixent added to 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, according to the companies.
Dupixent is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.
More than 90% of children in the trial had at least one concurrent type 2 inflammatory condition including atopic dermatitis and eosinophilic esophagitis, according to the press release. Safety results from the clinical trial were generally consistent with the known safety profile of Dupixent in patients aged 12 years and older with moderate-to-severe asthma.
“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 their 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 C. Reed, M.D., Ph.D., global head of research and development at Sanofi said in a press release. “Dupixent is the only biologic shown in a controlled Phase 3 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.
"Children with moderate-to-severe asthma live with a heavy and unpredictable disease
burden. Even while taking maximum treatments including inhaled corticosteroids, they suffer from multiple asthma attacks each year that may require hospitalization," said George D. Yancopoulos, M.D., Ph.D., president and chief scientific officer of Regeneron in press release from Regeneron. "These impressive Phase 3 data in children with asthma show Dupixent significantly reduced annual severe asthma attacks and also improved lung function consistently across patients with markers of type 2 inflammation."
Dupixent has been studied in more than 10,000 patients across 50 clinical trials in various chronic diseases driven by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying Dupixent in a broad range of diseases driven by type 2 inflammation or other allergic processes, including pediatric asthma (6 to 11 years of age, Phase 3), pediatric atopic dermatitis (6 months to 5 years of age, Phase 3), eosinophilic esophagitis (Phase 3), chronic obstructive pulmonary disease (Phase 3), bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), and food and environmental allergies (Phase 2). These potential uses are investigational, and the safety and efficacy of Dupixent in these conditions have not been evaluated by any regulatory authority.