Sanofi and Regeneron Pharmaceuticals on Friday said in a press release that trial Part A of the pivotal Phase 3 trial evaluating Dupixent (dupilumab) in patients 12 years and older with eosinophilic esophagitis (EoE) trial met both of its co-primary endpoints, as well as all key secondary endpoints.
Dupixent is the first and only biologic to show positive and clinically-meaningful results in this population as part of a Phase 3 trial. An ongoing Part B portion of the Phase 3 trial evaluates an additional Dupixent dosing regimen, the companies said.
EoE is a chronic and progressive type 2 inflammatory disease that damages the esophagus and prevents it from working properly, leading to difficulties swallowing. If untreated, symptoms and inflammation can progress, causing functional damage and scarring of the esophagus. EoE can lead to esophageal food impaction, requiring immediate emergency room visits. Almost half of the patients in this trial had prior procedures such as dilation of their esophagus, and almost three-quarters had previously been treated with corticosteroids. In the U.S., there are approximately 160,000 patients with EoE who are currently treated, of which an estimated 50,000 have failed multiple treatments.There are currently no therapies approved by the U.S. Food and Drug Administration (FDA).
George D. Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief Scientific Officer of Regeneron, said that 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.
He said that the data from the trial 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 the eosinophils in the esophagus did not demonstrate consistent clinical or anatomical improvements, he was quoted as saying in the press release. “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.”‘
“These data demonstrate Dupixent’s potential to continue to address treatment gaps across the spectrum of type 2 inflammatory diseases as common as asthma and as rare as eosinophilic esophagitis,” said John Reed, M.D, Ph.D, Global Head of Research and Development at Sanofi. “For the first time in a Phase 3 trial, patients reported an improvement in their ability to swallow food. For patients with eosinophilic esophagitis who are living with restricted diets and, in some cases, repeated hospital interventions, these findings are encouraging.”