Regeneron Pharmaceuticals Inc. (REGN) and Sanofi (SNY) announced Monday positive results from the second Dupixent (dupilumab) Phase 3 Eosinophilic Esophagitis trial that showed significant disease improvements. Data from the clinical trial program will be submitted to regulatory authorities by 2022.
The second Phase 3 trial assessed the investigational use of Dupixent in patients 12 years and older with eosinophilic esophagitis or EoE. The trial met its co-primary endpoints in patients taking Dupixent 300 mg weekly, showing significant improvements in clinical and histologic disease measures compared to placebo.
EoE is a progressive disease that damages the esophagus and impairs the ability to swallow. In the trial, 90% of participants had at least one coexisting type 2 inflammatory condition such as asthma or atopic dermatitis.
According to the companies, Dupixent is the only biologic medicine to show positive, clinically meaningful Phase 3 results in these patients.
In the latest trial, Dupixent 300 mg weekly significantly improved the ability to swallow and reduced eosinophils in the esophagus compared to placebo, reinforcing positive results from first Phase 3 trial.
In September 2020, the U.S. Food and Drug Administration granted Breakthrough Therapy designation to Dupixent for the treatment of patients 12 years and older with EoE. Dupixent was granted Orphan Drug designation for the potential treatment of EoE in 2017.
The companies will share detailed results from the trial at an upcoming medical meeting.
The clinical trial program is ongoing, with patients from the first and second trials continuing into a 28-week long-term extension trial (Part C). Full results from this trial will be available in 2022.
Dupixent was invented using Regeneron's proprietary VelocImmune technology. Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.
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