Sanofi and Regeneron Pharmaceuticals have revealed positive results from a Phase II investigational study of dupilumab, for the treatment of adults with moderate-to-severe eosinophilic oesophagitis.
Oesophagus
The study demonstrated that patients who were administered with treatment on a weekly basis experienced a significant improvement in the ability to swallow versus those who were given a placebo. Eosinophilic esophagitis is a chronic, allergic inflammatory diseases that can lead to difficulties swallowing and food impaction as a result of damage caused to the oesophagus.
“Clinical manifestations of eosinophilic oesophagitis in adults include difficulty swallowing and food impaction, which are consequences of pathological structural changes to the oesophagus. Natural history studies have demonstrated an association between duration of untreated disease and the development of these oesophageal changes,” said Ikuo Hirano, MD, professor of Medicine, Northwestern University Feinberg School of Medicine. “Currently, there are no FDA-approved therapies for eosinophilic oesophagitis. In this study, dupilumab, a monoclonal antibody targeting IL-4 and IL-13, significantly improved patients’ ability to swallow, inflammation of the oesophagus, and endoscopic signs of the disease. These positive Phase II results support further clinical development of dupilumab for patients with eosinophilic oesophagitis.”
Primary endpoint of the study, which was the change from baseline to week 10 in the patients’ ability to swallow (as measured by the Straumann Dysphagia instrument score), was achieved with a significant improvement in the treated arm of the study. Secondary endpoints of the study included the measures of the impact of dupilumab on endoscopic and histopathologic measures of disease severity, as well as symptoms, which were reduced in the treatment arm.
No new safety concerns were raised from this trial, however there was a higher rate of injection site reactions in the patients treated with dupilumab.
These results were presented at the World Congress of Gastroenterology (WCOG) held in partnership with The American College of Gastroenterology Annual Scientific Meeting (ACG 2017) in Orlando, Florida.
Dupilumab recently received orphan drug designation from the FDA for the potential treatment of eosinophilic oesophagitis. The potential use of dupilumab in eosinophilic oesophagitis is currently under clinical development and the safety and efficacy have not been fully evaluated by any regulatory authority.