Results from the phase 1/2 ALLIANCE trial, presented at the 2026 American Academy of Allergy, Asthma & Immunology Annual Meeting, indicate that a once-daily peanut sublingual immunotherapy (SLIT) tablet is well tolerated in children, adolescents, and adults as participants progressed to higher dose levels. Researchers are developing this tablet as a potentially simpler, more convenient alternative to existing therapies.
The trial targets a major unmet need in food allergy care. Edwin H. Kim, MD, MS, from the University of North Carolina School of Medicine, highlighted the necessity of this research, stating, “There’s an unmet need for a simple, convenient, user-friendly and safe treatment for peanut allergy that doesn’t have considerable restrictions on daily life.” Unlike oral immunotherapy, which involves swallowing peanut protein, SLIT involves a tablet that dissolves under the tongue.
The study was divided into two primary parts to evaluate safety and dose escalation. In the first part, 34 individuals between the ages of 12 and 65 were assigned to five increasing dose groups to determine the upper limits of tolerability. Results showed that adolescents and adults who completed most of their assigned doses met the study’s predefined tolerability criteria. Tolerability was defined as experiencing nothing more severe than local application site reactions of moderate intensity.
The second part of the trial expanded the age range to include children as young as 4 years old. In this phase, 32 participants followed a two-week up-dosing regimen. Across the pediatric, adolescent, and adult cohorts, the vast majority of patients successfully reached the highest dose steps. Notably, children in the cohort, which had a median age of 9 years, successfully tolerated the highest dose level in the up-dosing regimen.
Safety data showed that most treatment-emergent adverse events were mild. The most common issues reported by participants included oral pruritus (itchy mouth) at 88%, throat irritation at 84%, and stomach pain at 50%. While a small number of participants discontinued the study due to adverse events, researchers noted that reactions were generally non-severe in intensity, with no systemic anaphylaxis reported.
The trial also monitored for events of special interest, such as systemic allergic reactions or severe throat swelling. These events were not observed, reinforcing the safety profile of the sublingual approach. One participant received epinephrine during the study; however, no systemic anaphylaxis was reported, and the individual was able to complete the up-dosing regimen.
Looking ahead, the research team is continuing development to further evaluate the therapy. “Part three (phase 2) of the ALLIANCE study, which includes an up-dosing regimen followed by 24 weeks of maintenance treatment, is currently underway at 40 sites across the U.S. and Canada,” according to the trial presentation. Dr Kim added that the team is “hopeful to have topline results by quarter two of this year.”
Dr Kim received a $1M grant in 2024 to study SLIT treatment for multi-nut allergies.
