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 assess the effectiveness, safety, and tolerability of Itepekimab, an anti-IL-33 monoclonal antibody, as an add-on therapy for patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
Intervention/Treatment: The trial tests Itepekimab, administered subcutaneously in high and low doses, alongside Mometasone furoate nasal spray. The purpose is to improve symptoms in patients with inadequately controlled CRSwNP.
Study Design: This interventional study is randomized with a parallel assignment model. It employs quadruple masking, meaning participants, care providers, investigators, and outcomes assessors are blinded. The primary purpose is treatment-focused.
Study Timeline: The study began on February 12, 2025, with recruitment ongoing. Primary completion is anticipated within 52 weeks of the start date, with the last update submitted on August 6, 2025.
Market Implications: The ongoing study could significantly impact the stock performance of Regeneron and Sanofi, especially if Itepekimab proves effective. Positive results may enhance investor sentiment and position the companies favorably against competitors in the CRSwNP treatment market.
The study is currently recruiting, with further details available on the ClinicalTrials portal.