Regeneron Pharmaceuticals Inc. and French pharmaceutical company Sanofi announced that the companies’ drug, dupilumab, showed positive results in adults with eosinophilic esophagitis, an allergic inflammatory disease that damages the esophagus.
Food allergies are the main cause of eosinophilic esophagitis. Corresponding with the increase of allergic diseases in the overall population, incidences of eosinophilic esophagitis are also rapidly increasing.
As part of the 12-week Phase 2 study, 47 patients were randomized into two treatment groups where they received either 300 mg of dupilumab weekly or a placebo. At week 10, patients who received dupilumab reported a statistically significant improvement in their ability to swallow compared to those who received a placebo.
The results of the study were presented at the World Congress of Gastroenterology in Orlando, Florida.
“Currently, there are no FDA-approved therapies for eosinophilic esophagitis,” said Dr. Ikuo Hirano, professor of medicine at Northwestern University Feinberg School of Medicine. “These positive phase 2 results support further clinical development of dupilumab for patients with eosinophilic esophagitis.”
Dupilumab has received Orphan Drug Designation from the FDA, a status given to investigational drugs that are being developed for the treatment of diseases or conditions that affect fewer than 200,000 people in the United States.