ALLIANCE Trial: Peanut Sublingual Immunotherapy Is Well-Tolerated in Children With Peanut Allergy

Preliminary results from the phase 1/2 ALLIANCE trial (NCT05440643) presented at the 2026 American Academy of Allergy, Asthma & Immunology Annual Meeting in Philadelphia, Pennsylvania, and published in the Journal of Allergy and Clinical Immunology, indicate that the peanut sublingual immunotherapy (SLIT) tablet (ALK-Abelló) is well-tolerated in children, adolescents, and adults with peanut allergy.¹ If research continues to demonstrate its efficacy and safety, the peanut SLIT tablet can become another option for patients who have peanut allergy.^1,2

In the US, peanut allergy affects up to 1.5 million children and adolescents aged 4 to 17 years, whereas in Europe, approximately 1 million children and adolescents are affected by this potentially life-threatening condition. The disease often presents in early childhood and can last a lifetime, and for some patients, allergy immunotherapy may become a relevant treatment option with the potential to improve quality of life, both for themselves and their families. SLIT tablets have previously demonstrated tolerability and efficacy in treating aeroallergen allergies, and they may present as a treatment option for peanut allergy.^2,3

“SLIT is not a cure, but by striking that balance of protecting against allergic reactions while still being easy and safe to do, it could have the potential to help a lot of peanut-allergic patients and their families,” study author Edwin Kim, MD, MS, from the University of North Carolina School of Medicine, said in a news release.⁴

The ALLIANCE trial (NCT05440643), a dose-escalation, multisite phase 1/2 clinical trial evaluating the safety, tolerability, and efficacy of the peanut SLIT tablet in adults, adolescents, and children with peanut allergy consists of 3 parts:⁴

• Part 1: Participants first receive a peanut SLIT tablet with 1 of 5 doses once per day for 2 weeks;
• Part 2: Then, participants receive a series of increasing doses of the peanut SLIT tablet. Each dose is taken once per day for 2 weeks and the initial entry dose is determined from part 1;
• Part 3: Finally, subjects are randomly assigned into 3 treatment groups—up-dosing regimen [UDR] and maintenance A, UDR and maintenance B, or placebo UDR and placebo—and receive a series of increasing doses of the peanut SLIT tablet. Each dose is taken once per day for 2 weeks, followed by maintenance A or B once per day for 24 weeks, or the corresponding placebo.

Participants in the trial were 4 to 65 years of age with peanut allergy. In Part 1, participants (n = 34) in 5 open-label cohorts received 1 of 5 escalating doses daily for 2 weeks to determine the entry dose for the UDR in part 2. In part 2, participants (n = 32) received an open-label UDR of 5 doses, each for 2 weeks daily, beginning with the entry dose determined in part 1. The primary end point in both parts 1 and 2 was dose tolerability, and the secondary end point was frequency of treatment-emergent adverse events (TEAEs).^1,2

In part 1 of the trial, all participants tolerated their assigned dose. There were no TEAEs that specifically led to discontinuation, no systemic allergic reactions, no epinephrine administrations, no severe swelling of the mouth or throat that required epinephrine, and no cases of eosinophilic esophagitis developed.²

In part 2, 27 of the 32 participants tolerated the highest UDR dose, and 4 participants discontinued because of TEAEs. The most common TEAEs were mild to moderate oral pruritus, throat irritation, and stomach pain. There were 2 systemic allergic reactions (nonsevere; no anaphylaxis) that were not treated with epinephrine, a local reaction of gastrointestinal symptoms (moderate intensity; UDR completed) treated with epinephrine, no severe swelling of mouth/throat, and no cases of eosinophilic esophagitis developed.²

These safety findings support previous data, which demonstrated that peanut SLIT was safe and induced clinically significant desensitization in most of the children enrolled. Specifically, 47 (87%) of the 54 enrolled participants completed peanut SLIT and the 48-month double-blind, placebo-controlled food challenge (DBPCFC) per protocol. The mean successfully consumed dose (SCD) during the DBPCFC increased from 48 to 2723 mg of peanut protein after SLIT (P < .0001), with approximately 70% achieving clinically significant desensitization (SCD > 800 mg) and 36% achieving full desensitization (SCD = 5000 mg). Modeled median time to loss of clinically significant desensitization was 22 weeks.

Additionally, the peanut skin prick test; peanut-specific immunoglobulin E (IgE), IgG4, and IgG4/IgE ratio; and peanut-stimulated basophil activation test, IL-4, IL-5, IL-13, IFN-γ, and IL-10 changed significantly compared with baseline, with changes observed as early as 6 months. The median rate of reaction per dose was 0.5%, with transient oropharyngeal itching being the most common. There were no dosing symptoms requiring epinephrine.⁵

Pharmacists should understand that SLIT is not curative, but it may provide clinically meaningful desensitization for patients while requiring daily administration and structured up-dosing and maintenance phases. They serve as educators for patients and caregivers on expectations, adherence to dosing schedules, recognition and management of AEs, and appropriate use of epinephrine when indicated. Additionally, pharmacists are also well-positioned to reinforce that desensitization may wane after discontinuation, assess for contraindications or comorbid atopic conditions, coordinate with allergists on monitoring, and help patients weigh this potential therapy alongside existing avoidance strategies and other immunotherapy options to support shared, informed decision-making.

REFERENCES

1. Peanut Sublingual Immunotherapy (SLIT)-Tablet for Treatment of Peanut Allergy. ClinicalTrials.gov identifier: NCT05440643. Updated January 30, 2026. Accessed February 28, 2026. https://clinicaltrials.gov/study/NCT05440643

2. Kim E, Zhou S, Hargreaves K, et al. Preliminary Safety and Tolerability Results from ALLIANCE, a Phase I/II Trial of a Peanut Sublingual Immunotherapy Tablet. J Allergy Clin Immunol. 2026;157(2, Supplement):AB188. doi:10.1016/j.jaci.2025.12.565

3. Positive results advance peanut tablet to phase II development. ALK. News release. December 18, 2024. Accessed February 28, 2026. https://ir.alk.net/news-releases/news-release-details/positive-results-advance-peanut-tablet-phase-ii-development

4. Novel peanut allergy treatment shown to be safe, effective and lasting UNC Chapel Hill. News release. March 28, 2023. Accessed February 28, 2026. https://www.unc.edu/posts/2023/03/28/novel-peanut-allergy-treatment-shown-to-be-safe-effective-and-lasting/

5. Kim EH, Keet CA, Virkud YV, et al. Open-label study of the efficacy, safety, and durability of peanut sublingual immunotherapy in peanut-allergic children. J Allergy Clin Immunol. 2023 Jun;151(6):1558-1565.e6. doi:10.1016/j.jaci.2023.01.036. Epub 2023 Feb 23. PMID: 36828080; PMCID: PMC10257751.