Regeneron Pharmaceuticals and Sanofi said that their co-developed eczema drug Dupixent (dupilumab) has met the co-primary endpoints of Part A of a phase 3 trial in patients 12 years and older who have eosinophilic esophagitis (EoE).
The late-stage trial also all the key secondary endpoints.
Dupixent is now the first and only biologic to demonstrate positive and clinically-meaningful results in the patient population as part of a phase 3 trial. An ongoing Part B segment of the phase 3 trial is evaluating an additional dosing regimen for Dupixent.
Part A of the phase 3 trial featured 81 patients, of which 42 were in the Dupixent arm, while the other 39 were put in the placebo group.
The co-primary endpoints evaluated the variation from baseline in the Dysphagia Symptom Questionnaire (DSQ), which is a patient-reported measure of difficulty swallowing, and the proportion of patients reaching peak esophageal intraepithelial eosinophil count of ≤6 eos/hpf, which is a measure of esophageal inflammation, at 24 weeks.
According to Regeneron Pharmaceuticals and Sanofi, 69% of patients subjected to Dupixent 300mg weekly had reduction in disease symptoms compared to 32% for placebo. Disease symptoms were measured by the DSQ scale, where patients saw a 21.92 point improvement with Dupixent, in comparison to a 9.60 point improvement for placebo, on a 0-84 scale, which is the co-primary endpoint.
Also, Dupixent 300mg delivered a 60% reduction in the patients’ esophageal eosinophilic count to a normal range in comparison to 5% for placebo, which is another co-primary endpoint of the phase 3 trial.
George D. Yancopoulos – Co-Founder, President, and Chief Scientific Officer of Regeneron Pharmaceuticals said: “Eosinophilic esophagitis can be debilitating, and there are no approved treatment options. It impacts patients’ ability to eat, causes severe pain and often results in repeated emergency room visits and medical procedures.
“These data are particularly impressive, as Dupixent not only dramatically reduced eosinophils in the esophagus, but also improved all clinical, anatomic and histologic measures of the disease. In the past, EoE was thought to be a disease caused by eosinophils, but other biologics that decrease eosinophils in the esophagus did not demonstrate consistent clinical or anatomical improvements.
“These Dupixent results demonstrate EoE is caused by multiple aspects of type 2 inflammation, driven by interleukin-4 and interleukin-13. EoE is the fourth atopic or type 2 inflammatory disease in which Dupixent has pivotal data demonstrating significant efficacy.”