AAAAI 2026 Recap: 5 Trials for Primary Care to Know

At the 2026 American Academy of Allergy, Asthma, & Immunology annual meeting, held February 27 to March 2, 2026, in Philadelphia, PA, a range of new clinical data was presented that highlighted emerging therapies and prevention strategies across several allergic and immunologic diseases. The research spans early-phase therapeutic development, microbiome-based interventions, and prevention-focused trials targeting atopic disease and asthma in early life.

Among the studies presented were new findings on navenibart, a monoclonal antibody targeting plasma kallikrein for hereditary angioedema (HAE); STMC-103H, a live biotherapeutic product designed to reduce the risk of atopic dermatitis and food allergy in infants; and the ORBEX trial, which is evaluating whether oral bacterial extracts may prevent wheezing and asthma in early childhood. Additional data included results from a phase 2 study of the anti-IgE antibody LP-003 for refractory chronic spontaneous urticaria (CSU) and findings from the APEX trial assessing the long-acting anti-IL-13 antibody APG777 in adults with moderate-to-severe atopic dermatitis. Together, these studies highlight evolving strategies aimed at improving disease control and potentially preventing allergic disease development.

Navenibart Delays First Hereditary Angioedema Attack in ALPHA-STAR Trial

In the phase 1b/2 ALPHA-STAR trial, treatment with the long-acting monoclonal antibody navenibart, a plasma kallikrein inhibitor, reduced hereditary angioedema (HAE) attack frequency and substantially prolonged the time to first attack. Among 29 adults with HAE, the mean monthly attack rate declined from 2.23 at baseline to 0.31 after treatment, and the median time to first attack reached 241 days after the first dose. Navenibart was well tolerated with no serious treatment-emergent adverse events, supporting further investigation in the ongoing phase 3 ALPHA-ORBIT trial (NCT068428).¹

STMC-103H Shows Potential to Reduce Atopic Disease Risk in Infants in ADORED Trial

Results from the phase 1b/2 ADORED trial suggest that STMC-103H, a live biotherapeutic targeting the infant gut microbiome, may reduce the risk of developing atopic disease in infants with a family history of allergic conditions. Among infants who completed the treatment regimen, STMC-103H reduced the risk of physician-diagnosed atopic dermatitis by 64% (23.3% vs 43.1%; OR 0.36) and food allergy by 77% (4.7% vs 16.7%) compared with placebo. The therapy was well tolerated, although efficacy signals were not statistically significant when all randomized infants were included in the analysis.²

ORBEX Trial Evaluates Oral Bacterial Extracts for Primary Prevention of Childhood Asthma

The ORBEX trial is investigating whether early-life exposure to oral bacterial lysates can reduce the risk of wheezing and asthma in children at increased risk of allergic disease. In the study, 822 children aged 6–18 months with atopic dermatitis or a family history of asthma were randomized to receive OM-85 (Bronchovaxom) or placebo for 10 days each month over two years. The trial’s primary endpoint—time to first wheezing episode requiring oral corticosteroids or lasting longer than 24 hours—will be assessed after completion of a three-year observation period, with final results expected in 2026.³

LP-003 Demonstrates Improved Disease Control in CSU

In a phase 2 randomized trial, the investigational anti-IgE antibody LP-003 demonstrated significant improvements in disease activity among patients with refractory CSU. At week 12, 66.7% of patients receiving LP-003 200 mg every 8 weeks achieved complete disease control (UAS7=0) compared with 43.6% with omalizumab and 10.8% with placebo. LP-003 also produced greater reductions in UAS7 scores versus omalizumab and was well tolerated with no drug-related serious adverse events.⁴

APG777 Shows High EASI-75 Response Rates in Atopic Dermatitis in APEX Study

The phase 2 APEX study evaluated APG777, a half-life-extended anti-IL-13 antibody, in adults with moderate-to-severe atopic dermatitis. At week 16, 74.7% of patients treated with APG777 achieved EASI-75, compared with 26.3% receiving placebo (P < .001). Treatment responses were consistent regardless of comorbid type 2 inflammatory conditions, including asthma and sinonasal disease, and no new safety signals were identified.⁵

References:

1. Tachdjian R, Riedl M, Li H, et al. Navenibart delays time to first attack in hereditary angioedema: Results from ALPHA-STAR. J Allergy Clin Immunol. 2026;157(2):AB14. doi:10.1016/j.jaci.2025.12.047
2. O’Sullivan M, Vickery B, Varshney P, et al. STMC-103H reduces risk of atopic dermatitis and food allergy in at-risk infants: Results of the phase 1b/ 2 randomized, double-blind, placebo-controlled ADORED trial. J Allergy Clin Immunol. 2026;157(2):AB423. doi:10.1016/j.jaci.2025.12.938
3. Martinez F, Mauger D, Bacharier LB, et al. Primary prevention of asthma: the ORBEX trial. J Allergy Clin Immunol. 2026;157(2):AB414. doi:10.1016/j.jaci.2025.12.912
4. Hu F, Wu L, Han C, et al. LP-003 significantly decreases chronic spontaneous urticaria disease activity and is well tolerated: Top line results from a phase 2 trial. J Allergy Clin Immunol. 2026;157(2):AB424. doi:10.1016/j.jaci.2025.12.941
5. Stein Gold, L, Silverberg J, Blauvelt A, et al. Efficacy of APG777 in patients with atopic dermatitis and evidence of type 2 inflammatory comorbidities: Results from the phase 2 APEX study. J Allergy Clin Immunol. 2026;157(2):AB424. doi:10.1016/j.jaci.2025.12.942