Peanut Allergy: SLIT Tablet Well-Tolerated in Phase 1/2 Trial

Philadelphia – A once-daily peanut sublingual immunotherapy (SLIT) tablet appears to be well tolerated across a broad age range – from children as young as four to adults aged 65 – in an ongoing clinical trial, offering a potential recent avenue for managing peanut allergy. The phase 1/2 ALLIANCE trial data, presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting this week, suggest the treatment is safe, with most adverse events being mild to moderate in severity. Healio News reported on the findings.

Study Design and Findings

The open-label ALLIANCE trial involved two parts. The first phase assessed tolerability of increasing doses of the SLIT tablet in 34 individuals aged 12 to 65. Participants received one of five escalating doses daily for two weeks. The second phase, involving 32 individuals aged 4 to 65, utilized an up-dosing regimen of five doses, with each dose administered daily for two weeks. This phase further categorized participants by age – children (median age 9 years), adolescents (median age 13 years) and adults (median age 20.5 years) – with two individuals identified as “highly sensitized” evaluated separately.

Researchers found that the highest dose in the up-dosing regimen was tolerated by 27 of 32 participants. Adolescents and adults generally demonstrated good tolerability, with most experiencing only mild adverse events. Notably, all children in the study tolerated the highest up-dosing regimen dose. The SLIT tablet contains peanut extract with a standardized amount of major allergens (Ara h 1, 2, 3, 6), aiming to desensitize individuals to peanut allergens through consistent, low-dose exposure.

Safety Profile

The most frequently reported adverse events were mild, including oral pruritus (itching) reported in 88% of participants, throat irritation in 84%, and stomach pain in 50%. Moderate adverse events were reported in nine individuals, and only one experienced a severe event. Importantly, no treatment-related adverse events led to trial discontinuation, and no participants experienced severe allergic reactions requiring epinephrine. Two systemic allergic reactions were observed, but these were described as non-severe and did not necessitate epinephrine administration. The full study abstract, presented at AAAAI, provides further details on the safety profile.

Addressing an Unmet Demand

“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,” explained Edwin H. Kim, MD, MS, FAAAI, associate professor of pediatrics at the University of North Carolina School of Medicine, during his presentation. Current peanut allergy management often involves strict avoidance and carrying epinephrine auto-injectors, which can significantly impact quality of life. Sublingual immunotherapy offers a potential alternative that could reduce the risk of accidental reactions and lessen the burden of constant vigilance.

What the Data Suggests – and Doesn’t

It’s crucial to understand that these are phase 1/2 trial results. Although encouraging, they primarily focus on safety and tolerability, not efficacy. The study does not yet demonstrate whether the SLIT tablet will provide long-term protection against allergic reactions or reduce the severity of reactions if they do occur. The trial design, being open-label, also means that both participants and researchers were aware of the treatment being administered, which could introduce bias. A placebo-controlled phase 3 trial is necessary to confirm these findings and establish the treatment’s effectiveness.

The Next Phase: Maintenance Treatment and Long-Term Outcomes

Phase 3 of the ALLIANCE study is currently underway at 40 sites across the U.S. And Canada. This phase will involve an up-dosing regimen followed by 24 weeks of maintenance treatment. Researchers anticipate topline results by the second quarter of 2026. The goal of the maintenance phase is to assess whether continued exposure to the SLIT tablet can induce sustained tolerance to peanuts. The study is funded by ALK, and Dr. Kim has disclosed consulting fees and research grants related to the study. Previous research on sublingual immunotherapy for peanut allergy has shown promising results in younger children, further fueling interest in this approach.

Understanding Sublingual Immunotherapy

Sublingual immunotherapy (SLIT) involves placing a small amount of allergen extract under the tongue. This method of administration is thought to stimulate the immune system to become less reactive to the allergen over time. Unlike traditional allergy shots (subcutaneous immunotherapy), SLIT is typically administered at home, making it more convenient for patients. However, it’s critical to note that SLIT is not a cure for peanut allergy, and individuals will likely still need to exercise caution and carry epinephrine auto-injectors, particularly during the initial stages of treatment. The National Institute of Allergy and Infectious Diseases (NIAID) provides comprehensive information on food allergies and ongoing research efforts. Learn more about food allergies from NIAID.

As the ALLIANCE study progresses, it will be crucial to monitor the long-term safety and efficacy of the SLIT tablet. If successful, this treatment could offer a significant improvement in the management of peanut allergy, providing individuals with greater freedom and peace of mind.