Regeneron Pharmaceuticals ((REGN)), Sanofi ((SNYNF)) announced an update on their ongoing clinical study.
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Study Overview: Regeneron Pharmaceuticals and Sanofi have completed a Phase 3 clinical study titled Randomized, Double-blind, Placebo-controlled, Parallel Group Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD). The study aimed to assess the efficacy, safety, and tolerability of Itepekimab in reducing acute exacerbations of COPD in former smokers, with secondary objectives including improvements in pulmonary function and quality of life.
Intervention/Treatment: The study tested Itepekimab, an anti-IL-33 monoclonal antibody, administered subcutaneously either every two weeks or every four weeks, with a placebo group for comparison. The treatment was designed to reduce COPD exacerbations and improve respiratory health.
Study Design: This interventional study was randomized and used a parallel assignment model. It employed a quadruple masking approach, meaning that participants, care providers, investigators, and outcomes assessors were blinded to the treatment allocation. The primary purpose was treatment-focused, aiming to evaluate the therapeutic potential of Itepekimab.
Study Timeline: The study began on December 30, 2020, and was completed by September 26, 2025. These dates are crucial as they mark the study’s duration and the timeline for data collection and analysis, which is vital for understanding the study’s findings and potential market impact.
Market Implications: The completion of this study could significantly impact Regeneron and Sanofi’s market positions, potentially boosting investor confidence and stock performance if results are favorable. The COPD treatment market is competitive, with significant interest from pharmaceutical companies, making successful outcomes from this study particularly impactful.
The study is completed, and further details are available on the ClinicalTrials portal.