Top Trial Recaps from ACAAI 2025

As part of HCPLive’s on-site coverage of the 2025 American College of Allergy, Asthma, & Immunology (ACAAI) Scientific Meeting in Orlando, Florida, our team connected with 19 experts across allergy, immunology, and dermatology from November 6 – 10. This year’s sessions highlighted an especially active pipeline, with data spanning hereditary angioedema (HAE), chronic spontaneous urticaria (CSU), chronic rhinosinusitis, pediatric atopic dermatitis, and emerging approaches for type 2 inflammatory diseases.

From rapid-acting rescue therapies to new anti-inflammatory strategies and potential steroid-sparing options, investigators shared late-breaking findings that may influence both near-term decision-making and future treatment pathways.

Here, we spotlight 4 late-breaker studies featured in our coverage, along with 2 phase 3 trials presented at the meeting.

Late Breakers at ACAAI 2025

Sublingual Epinephrine Film Rapidly Works in Children, With David Golden, MD

Phase 1 findings presented at ACAAI 2025 demonstrated that AQST-109 (Anaphylm), a sublingual epinephrine film, quickly achieves therapeutic drug levels in pediatric patients. In discussion with HCPLive, David Golden, MD, noted cardiovascular effects were detectable within 2 minutes, with clinically meaningful plasma concentrations reached by 5 to 8 minutes and peak levels around 10 minutes. Physiologic responses in children aged 7–17 years mirrored adult data, supporting a fast, needle-free alternative that maintains established safety expectations.

Benralizumab Reduces HES Flare in Phase 3 Trial, With Princess Ogbogu, MD

Princess Ogbogu, MD, of University Hospitals Rainbow Babies & Children’s Hospital, reviewed phase 3 NATRON results evaluating benralizumab in hypereosinophilic syndrome (HES). Patients aged ≥12 years with steroid-responsive disease experienced fewer flares, longer flare-free intervals, and lower annualized flare rates compared with placebo. Fatigue scores improved by week 4 and remained stable through week 24. Safety outcomes were consistent with the benralizumab profile seen in other eosinophil-driven conditions.

Sebetralstat Shows Promise for On-Demand HAE Treatment in Children, With Adil Adatia, MD

Interim results from the KONFIDENT-KID trial, discussed by Adil Adatia, MD, from the University of Alberta, evaluated oral sebetralstat in children aged 2–11 years with HAE. Young participants were able to take the fast-dissolving tablet shortly after symptom onset, supporting early at-home use. No treatment-emergent adverse events were reported, and pharmacokinetics aligned with adult findings. Median time to first improvement was 4 hours, suggesting a practical oral alternative to intravenous on-demand therapies.

Povorcitinib Improves Itch, Hive CSU Symptoms Within 3 Days, With Weilly Soong, MD

Weilly Soong, MD, of AllerVie Health – Homewood, discussed phase 2 data showing rapid symptom reduction with the JAK1 inhibitor povorcitinib in CSU. Patients receiving 75 mg achieved a 22% improvement in UAS7 and experienced meaningful relief of itch and hives within 3 days, quicker than timelines typically observed with available biologics and similar to BTK inhibitors. By week 12, approximately half of the participants achieved complete hive or itch resolution. Adverse events were primarily mild, though program development is currently paused.

Phase 3 Trials Presented at ACAAI 2025

Dupilumab Shows Promise for Allergic Fungal Rhinosinusitis in Phase 3 Trial, With Amber Luong, MD, PhD

Amber Luong, MD, PhD, of UT Health Houston, examined phase 3 LIBERTY AIMS results in allergic fungal rhinosinusitis (AFRS), a chronic rhinosinusitis subtype often excluded from biologic studies. Dupilumab produced marked reductions in sinus opacification, nasal polyps, and congestion, with a 50% improvement in CT scores versus 9.8% with placebo at week 52. The need for surgery or systemic steroids fell by 92%. Safety remained aligned with dupilumab's known tolerability. FDA consideration is pending.

Tapinarof Shows Early, Sustained Benefits in Pediatric Atopic Dermatitis, With Druhan Howell, MD

Druhan Howell, MD, an internal medicine and pediatrics-trained allergist practicing in Mobile, Alabama, and an Organon Health Partner, reviewed a pooled subanalysis of the phase 3 ADORING 1 and 2 trials examining 1% tapinarof cream in children aged 2–17 years with atopic dermatitis. Children with comorbid allergic conditions, such as asthma, allergic rhinitis, or food allergies, improved at rates comparable to those without comorbidities. Early skin improvements were evident by week 1, with significant gains in EASI-75, itch reduction, sleep, and POEM scores by week 2 and sustained through week 8. Safety findings aligned with previously published pediatric and adult data.