ALK has announced positive interim results from its Phase I/II clinical trial (ALLIANCE) for a sublingual immunotherapy (SLIT) tablet targeting peanut allergy. The trial's initial phase focused on assessing the safety and tolerability of multiple doses of the peanut tablet.
The Phase I/II trial involved approximately 30 patients who received daily doses of the peanut tablet for ten weeks. The results indicated that the tablet was safe and well-tolerated at all dose levels tested. Most treatment-related side effects were mild to moderate, transient, and localized to the application site. Notably, no serious adverse events or cases of treatment-emergent anaphylaxis were reported during this phase.
"We are very excited to report further positive progress with our ALLIANCE trial, which addresses the potentially life-threatening peanut allergy. We are beginning to see the contours of a simple, convenient, and safe medicine that may become an important treatment option for patients whose life is profoundly impacted by the disease," said Henriette Mersebach, Executive Vice President of R&D at ALK.
Based on these findings, ALK has selected treatment doses for the Phase II portion of the trial. This phase will evaluate the safety and efficacy of two different dosing regimens compared to placebo, using an oral food challenge to assess outcomes after a maintenance treatment period. The selected doses align with external data demonstrating clinically meaningful efficacy. The Phase II trial is expected to enroll approximately 125 patients, aged four to 65, across sites in the USA and Canada, with completion anticipated in 2026. Dosing of the first patients in Phase II is expected to begin imminently.
Peanut allergy affects up to 1.5 million children and adolescents aged four to 17 in the USA and approximately one million children and adolescents in Europe. The condition often manifests in early childhood and can persist throughout life. Allergy immunotherapy represents a potential treatment option to improve the quality of life for affected individuals and their families.
ALK plans to advance the peanut SLIT-tablet into Phase III development, contingent on successful Phase II results, followed by submission for regulatory approval, expected in the late 2020s. The peanut tablet is the lead product in ALK’s food allergy portfolio, which includes other preclinical programs targeting different pathways and indications.
