Regeneron Pharmaceuticals Inc. and Sanofi said two late-stage studies of Dupixent met the same main goal of improving nasal congestion and obstruction in patients with a certain allergy-related inflammatory condition.
The two phase 3 trials, known as Sinus-24 and Sinus-52, involved 276 and 448 adult patients, respectively, who had inadequately controlled chronic rhinosinusitis with nasal polyps. The patients were suffering from moderate or severe symptoms of nasal congestion, loss of smell or nasal discharge even after being treated with systemic corticosteroids — anti-inflammatory medicines given orally or by injection — or going through surgery.
Chronic rhinosinusitis with nasal polyps, or CRSwNP, is a chronic disease in which a type 2 or allergic inflammation causes nasal polyps — soft, painless, noncancerous growths — that obstruct the sinus and nasal passages. The condition is characterized by severe congestion, nasal discharge, facial pain or pressure, along with reduced sense of smell and taste.
In the late-stage studies, patients treated with a combination of Dupixent and standard-of-care corticosteroid nasal spray saw improvements in the severity of nasal congestion and obstruction by 51% and 57%, compared to 15% and 19% for those who received nasal spray alone.
The Dupixent-treated patients also saw 27% and 33% reduction in the size of their nasal polyps, while the placebo group had a 4% and 7% increase in polyp size.
Further, the trials met all secondary endpoints such as the significant reduction in the need for systemic corticosteroids or surgery, as well as improved smell and chronic rhinosinusitis symptoms of the patients.
Dupixent, or dupilumab, is currently approved to treat adult patients with moderate-to-severe atopic dermatitis — a type of eczema — that is not well controlled by prescription therapies used on the skin, or who cannot use topical therapies.
The drug is under regulatory review as an add-on maintenance therapy for asthma in the U.S. and EU.
Regeneron and Sanofi are also evaluating Dupixent in late-stage trials involving children with asthma and atopic dermatitis, as well as adolescent atopic dermatitis and eosinophilic esophagitis, an allergy of the esophagus causing the white blood cell called eosinophil to build up in the organ. It is also under mid-stage studies for treating glass allergy and peanut allergy.
The two companies intend to examine Dupixent in patients with chronic obstructive pulmonary disease, a group of progressive lung diseases including emphysema, chronic bronchitis and non-reversible asthma.