Regeneron Reports Positive Results From Dupixent Phase 3 Trial In 1 To 11 Yrs With EoE

(RTTNews) - Regeneron Pharmaceuticals Inc. (REGN) and Sanofi (SNY, SNYNF) on Tuesday presented late-breaking positive results from a Phase 3 trial evaluating the investigational use of Dupixent (dupilumab) in children aged 1 to 11 years with active eosinophilic esophagitis or EoE. The data showed significant histological remission of EoE in the age group.

The company noted that it is the first and only Phase 3 trial to show positive results in this patient population. There are currently no approved treatments specifically indicated for children under 12 years of age with EoE, a chronic inflammatory disease that damages the esophagus and prevents it from working properly.

In the randomized, placebo-controlled Phase 3 trial, Dupixent led to significant improvements in the primary efficacy measure for higher and lower dose groups at 16 weeks.

A majority of children on Dupixent, up to 68% on a higher dose and 58% of patients on lower dose, achieved the primary endpoint of significant histological disease remission at week 16, compared to 3% for placebo.

Safety results were generally consistent with the known safety profile of Dupixent in its approved EoE indication for children and adults aged 12 years and older who weigh at least 40 kg.

In May 2022, Dupixent 300 mg weekly was approved by the FDA to treat EoE in people aged 12 years and older, weighing at least 40 kg.

The company noted that the potential use of Dupixent in children with EoE aged 1 to 11 years is currently under clinical development, and the safety and efficacy have not been evaluated by any regulatory authority.

The trial is ongoing with a 36-week extended active treatment period, followed by a 108-week open-label extension to evaluate long-term outcomes.

The companies will share the latest data at United European Gastroenterology Week 2022 and submit to regulatory authorities around the world, starting with the U.S. Food and Drug Administration next year.

Mirna Chehade, principal investigator of the trial, said, "These Phase 3 data support the potential of dupilumab to reduce esophageal damage - caused in part by underlying type 2 inflammation - and showed histological disease remission and signs of weight gain impacting the growth percentile for those children on higher dose Dupixent."

Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. Dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.

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