Sanofi and Regeneron Pharmaceuticals Inc. said the phase 3 trial of Dupixent in adolescents with moderate-to-severe atopic dermatitis — a type of eczema — met its main goals.
The trial enrolled 251 patients aged 12 to 17 whose disease could not be controlled with topical medications or for whom topical therapies were medically inadvisable.
The late-stage study showed that 24% of patients who received a weight-based dose of Dupixent every two weeks and 18% who received a fixed dose every four weeks achieved clear or almost clear skin as measured by Investigator's Global Assessment score. Only 2% of the patients given placebo achieved the same level of clear skin.
Further, 41.5% of patients who were given Dupixent every two weeks and 38% who were given the drug every four weeks achieved at least a 75% skin improvement, as measured by the Eczema Area and Severity Index. Only 8% of the placebo group had the same level of skin improvement.
Atopic dermatitis is a chronic inflammatory disorder which causes rashes. Dupixent is already approved by the U.S. Food and Drug Administration for treating certain adults with atopic dermatitis.
The companies plan to submit data from the phase 3 trial to U.S. regulators by the third quarter of 2018. The U.S. FDA has granted Dupixent breakthrough therapy designation for treating moderate-to-severe atopic dermatitis for patients aged 12 to 17 years, and severe atopic dermatitis for patients aged six months to 11 years.
The French drugmaker and New York-based Regeneron are jointly developing Dupixent to treat a range inflammation-driven diseases. The companies are seeking U.S. and EU approvals for Dupixent as an add-on maintenance therapy for asthma.
