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Regeneron and Sanofi’s Phase 3 Trial for Itepekimab: A Potential Game-Changer in Chronic Rhinosinusitis Treatment

Regeneron and Sanofi’s Phase 3 Trial for Itepekimab: A Potential Game-Changer in Chronic Rhinosinusitis Treatment

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

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Study Overview: Regeneron Pharmaceuticals and Sanofi are conducting a Phase 3 clinical trial titled A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of Itepekimab in Adult Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps. The study aims to evaluate the efficacy, safety, and tolerability of Itepekimab as an add-on therapy to intranasal corticosteroids in adults with chronic rhinosinusitis with nasal polyps, a condition that significantly affects quality of life.

Intervention/Treatment: The study tests Itepekimab, an anti-IL-33 monoclonal antibody, administered subcutaneously. It aims to reduce inflammation and improve symptoms in patients with chronic rhinosinusitis with nasal polyps.

Study Design: This is a randomized, double-blind, placebo-controlled study with a parallel-group design. Participants are randomly assigned to receive either a high dose or low dose of Itepekimab or a placebo, alongside mometasone furoate nasal spray. The primary purpose is treatment, with quadruple masking to ensure unbiased results.

Study Timeline: The study began on February 12, 2025, with primary completion expected in 2026. The last update was submitted on June 25, 2025. These dates are crucial for tracking progress and anticipating results.

Market Implications: This study could significantly impact Regeneron and Sanofi’s stock performance, as successful results may lead to a new treatment option for chronic rhinosinusitis with nasal polyps. Investors should watch for updates, as positive outcomes could enhance market competitiveness against other pharmaceutical companies in the respiratory treatment sector.

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

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