Regeneron and Sanofi’s Dupilumab Study: A Potential Breakthrough for Pediatric Asthma

Regeneron Pharmaceuticals ((REGN)), Sanofi SA ((SNY)), Sanofi ((DE:SNW)), Sanofi ((SNYNF)) announced an update on their ongoing clinical study.

Study Overview: The clinical study titled A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Longterm Safety of Dupilumab in Children 2 to <6 Years of Age With Uncontrolled Asthma and/or Recurrent Severe Asthmatic Wheeze aims to evaluate the effectiveness and safety of dupilumab in young children suffering from uncontrolled asthma or severe asthmatic wheeze. This study is significant as it targets a vulnerable age group with limited treatment options, potentially offering a new therapeutic avenue.

Intervention/Treatment: The study tests the drug Dupilumab, administered via subcutaneous injection. Dupilumab is intended to manage symptoms and improve the quality of life for children with asthma or severe asthmatic wheeze.

Study Design: This is a Phase 3 interventional study with a randomized, parallel assignment. It employs triple masking, meaning the participant, care provider, and investigator are blinded to the treatment allocation. The primary purpose is treatment-focused, aiming to assess both efficacy and safety.

Study Timeline: The study began on January 3, 2024, with primary completion expected after the 52-week treatment period. The study’s estimated completion is in 2025, with the last update submitted on June 24, 2025. These dates are crucial for tracking progress and anticipating results.

Market Implications: This study could significantly impact Regeneron Pharmaceuticals and Sanofi’s market performance. Positive outcomes might boost investor confidence and stock prices, given the potential expansion in the pediatric asthma treatment market. Competitors in the respiratory treatment industry will be closely monitoring these developments.

The study is ongoing, with further details available on the ClinicalTrials portal.