Sanofi and Regeneron have unveiled positive results from a mid-stage study exploring the potential of the biologic dupilumab 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, with food allergies the main cause in a large number of patients.
Findings of the study, presented at the World Congress of Gastroenterology in Orlando, Florida, showed that patients who received dupilumab weekly reported a significant improvement in the ability to swallow versus placebo, with a 3 point reduction in SDI score (a patient-reported measure of swallowing difficulty), equating to 45 percent improvement, compared to a reduction of 1.3, or 19 percent improvement, respectively.
Secondary endpoints were also met, including a significant reduction in the mean change in the Eosinophilic Esophagitis Endoscopic Reference Score (EoE-EREFS), a visual measure of disease severity, by 1.9 versus 0.3, and the mean percent change in overall peak intraepithelial eosinophil count from baseline to 12 weeks by 93 percent versus an increase of 14 percent in those who received placebo.
An improvement was also observed in the mean percent change in a composite measure of symptoms and quality of life, as measured by Eosinophilic Esophagitis Symptom Activity Index (EEsAI), although the result did not reach statistical significance, the firm noted.
Current treatment options for people with moderate-to-severe eosinophilic esophagitis are limited to diet modification, corticosteroids or surgery, underscoring the need for new treatment options.
“In this study, dupilumab, a monoclonal antibody targeting IL-4 and IL-13, significantly improved patients’ ability to swallow, inflammation of the esophagus, and endoscopic signs of the disease. These positive Phase II results support further clinical development of dupilumab for patients with eosinophilic esophagitis,” noted Ikuo Hirano, Professor of Medicine, Northwestern University Feinberg School of Medicine.
Peanut allergy deal
Meanwhile, the companies have signed a deal with Brisbane, Calififornia-headquartered Aimmune Therapeutics to study AR101 treatment with adjunctive dupilumab in peanut-allergic patients in a Phase II clinical trial.
Regeneron will sponsor the trial, with Aimmune to provide clinical supply of AR101 and food challenge materials.
AR101 is Aimmune’s investigational biologic oral immunotherapy for desensitisation of patients with peanut allergy, and dupilumab is a human monoclonal antibody that inhibits signalling of IL-4 and IL-13 cytokines, which are believed to be major drivers of Type 2 inflammation.