Sanofi and Regeneron Pharmaceuticals Inc.'s phase 2 trial of dupilumab showed that the drug improved the ability to swallow versus placebo in adults with active moderate-to-severe eosinophilic esophagitis.
Eosinophilic esophagitis is a chronic, allergic inflammatory disease that damages the esophagus and prevents it from working properly, leading to difficulties swallowing and food impaction.
The main goal of the trial was the change from baseline to week 10 in a patient-reported measure of swallowing difficulty on a 0 to 9 point scale, with 9 indicating more severe symptoms. All patients irrespective of the treatment given had a baseline score of 6.4.
Patients receiving dupilumab showed significant improvement with a score of 3.4 at the end of 10 weeks, as compared to a score of 5.1 reported by patients receiving placebo.
The drug met all secondary endpoints by improving the symptoms and quality of life versus placebo. There were no new significant safety concerns in the trial.
Dupilumab recently received orphan drug designation from the U.S. Food and Drug Administration.
The drug is already approved in the U.S. and the EU for the treatment of moderate-to-severe atopic dermatitis, a type of skin inflammation.