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: The clinical study titled AIM4: Next Step – Asthma Uncontrolled With ICS in Medium Dose (GINA 4): Next Step is spearheaded by Regeneron Pharmaceuticals and Sanofi. It aims to evaluate the efficacy of adding dupilumab to a medium dose inhaled corticosteroid/long-acting beta-agonist (ICS/LABA) regimen compared to escalating to a high dose ICS/LABA in patients with uncontrolled asthma. This study is significant as it seeks to improve treatment outcomes for asthma patients who continue to experience symptoms despite current medication.
Intervention/Treatment: The study tests the drug dupilumab, administered via subcutaneous injection, in combination with ICS/LABA. The goal is to determine if this combination is more effective than increasing the ICS/LABA dosage alone for managing uncontrolled asthma symptoms.
Study Design: This Phase 3b interventional study employs a randomized, parallel assignment model with quadruple masking, ensuring that participants, care providers, investigators, and outcomes assessors are blinded. The primary purpose is treatment-focused, aiming to assess the comparative efficacy of the interventions.
Study Timeline: The study began on August 26, 2024, with its primary completion and estimated completion dates yet to be announced. The latest update was submitted on July 11, 2025. These dates are crucial for tracking the study’s progress and anticipating results.
Market Implications: The outcome of this study could significantly impact Regeneron and Sanofi’s stock performance, as positive results may enhance investor confidence and market position. Given the competitive landscape in asthma treatment, successful results could position these companies favorably against competitors, potentially influencing industry dynamics.
The study is currently ongoing, with further details available on the ClinicalTrials portal.