Written By: Pharmacally Medical News Desk
Sanofi and Regeneron have announced promising results from the pivotal Phase 3 LIBERTY-AFRS-AIMS study evaluating Dupixent (dupilumab) for allergic fungal rhinosinusitis (AFRS) in adults and children aged 6 years and older. The study met all primary and secondary endpoints, demonstrating significant clinical improvements in signs and symptoms of AFRS, a challenging subtype of chronic rhinosinusitis characterized by inflammation caused by allergic response to fungal elements in the sinuses.
The Phase 3 LIBERTY-AFRS-AIMS study (Clinical Trial ID: NCT04684524) is 52-week randomized, placebo-controlled interventional clinical trial. The study involved 62 participants and showed notable reductions in sinus opacification, nasal congestion, and nasal polyp size compared to placebo. Sinus opacification improved by 50.0% with Dupixent versus 9.8% with placebo. Nasal congestion/obstruction, a key patient-reported symptom, improved by 66.7% at 24 weeks and further to 80.6% at 52 weeks in the Dupixent group, compared to 25.3% and 11.1%, respectively, in the placebo group. Nasal polyp size was reduced by over 60% at both 24 and 52 weeks with Dupixent, significantly outperforming placebo.
Patients treated with Dupixent exhibited a 92% lower risk of requiring systemic corticosteroids or sinus surgery, underscoring the therapy’s potential to reduce disease burden and improve quality of life in AFRS patients.
The safety profile of Dupixent in this study was consistent with previous respiratory indication trials. Adverse events occurred in 70% of Dupixent-treated patients versus 79% in the placebo arm. The most common side effects included COVID-19 infections and nosebleeds, with no serious adverse events reported in the Dupixent group.
Following these positive pivotal results, Sanofi and Regeneron’s supplemental Biologics License Application (sBLA) for Dupixent in allergic fungal rhinosinusitis has been accepted by the US FDA for priority review. This designation expedites the review process for therapies that demonstrate significant improvements in serious conditions, highlighting the unmet need in AFRS management and Dupixent’s potential role as a new treatment option.
Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling pathways, key drivers of type 2 inflammation underlying diseases such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, and now allergic fungal rhinosinusitis.
Dupixent (dupilumab) is widely regarded as a miracle biotech product due to its groundbreaking ability to treat multiple allergic and atopic conditions by targeting key drivers of type 2 inflammation interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling pathways. Since its first approval in 2017, Dupixent has been approved globally for eight indications. In recognition of its extraordinary impact on patient care and innovative science, Dupixent was honored with the prestigious 2025 Prix Galien USA Award for Best Biotechnology Product.
Experts recognize this Phase 3 success as a milestone. Dr. Amber U. Luong, Vice Chair for Academic Affairs at the University of Texas Health Science Center, noted that the trial underscores the importance of IL-4 and IL-13 in AFRS pathophysiology and highlights Dupixent’s capacity to reduce hallmark symptoms and decrease surgical interventions.
The completion of the LIBERTY-AFRS-AIMS study with compelling efficacy and safety data marks a significant advancement in AFRS treatment. If approved, Dupixent would become the first targeted biologic specifically indicated for this rare and difficult-to-treat form of chronic rhinosinusitis, offering new hope to patients.
References
Press Release: ACAAI: Sanofi and Regeneron’s Dupixent pivotal study met all primary and secondary endpoints, reducing signs and symptoms of allergic fungal rhinosinusitis; sBLA accepted for FDA priority review, 07 November 2025, Sanofi, https://www.sanofi.com/en/media-room/press-releases/2025/2025-11-07-13-00-00-3183599
Dupilumab in Allergic Fungal Rhinosinusitis (AFRS) (LIBERTY-AFRS-AI), ClinicalTrials.gov ID NCT04684524, https://clinicaltrials.gov/study/NCT04684524
Cameron BH, Luong AU. New Developments in Allergic Fungal Rhinosinusitis Pathophysiology and Treatment, Am J Rhinol Allergy, 2023 Mar 37(2):214-220. Doi: 10.1177/19458924231152983. PMID: 36848273; PMCID: PMC11898383