Phase 1 Peanut SLIT-Tablet Trial's Initial Phase Completed by ALK

Phase 1 of a clinical trial for an innovative sublingual immunotherapy (SLIT) tablet, developed by ALK, has successfully concluded, paving the way for the next stages of the study. The tablet, designed to treat peanut allergy, demonstrated safety and tolerability over a 14-day period across various dosages. The trial, known as 'ALLIANCE,' did not report any serious adverse events or cases of treatment-related anaphylaxis.

Building on the positive initial findings, ALK is set to initiate the second phase of the trial, which will focus on the safety and tolerability of increasing the dosage to the highest maintenance dose that patients can tolerate. This phase is expected to be completed by the end of 2024.

Additionally, ALK plans to introduce a third phase to the ALLIANCE study, which will involve an additional 100 patients. The aim is to assess both the safety and efficacy of the peanut SLIT-tablet through an oral food challenge after a period of maintenance treatment. The introduction of this phase is dependent on the successful completion of the second phase, and the revised study protocol is anticipated to be submitted to regulatory authorities shortly.

Henriette Mersebach, ALK’s Executive Vice President of Research and Development, expressed satisfaction with the trial's progress and highlighted the company's commitment to developing new treatment options for allergy sufferers. Peanut allergy is a significant health concern, affecting approximately 1.5 million children and adolescents in the United States and around 1 million in Europe. The condition often emerges in early childhood and can persist throughout an individual's life, potentially impacting the quality of life for both the affected individuals and their families.

The positive developments from the ALLIANCE trial are not anticipated to significantly alter ALK's projected R&D expenses for the years 2024-25. ALK, headquartered in Denmark, is a global pharmaceutical company specializing in allergy and allergic asthma treatments, with a workforce of approximately 2,800 employees and a presence on Nasdaq Copenhagen.

The ALLIANCE trial, which began in 2022, is a phase I, open-label, dose-escalation study conducted across multiple sites in North America. It involves around 100 participants with confirmed peanut allergies, who were screened through a double-blind, placebo-controlled food challenge. The trial's first part was dedicated to determining the starting dose for the up-dosing regimen, while the second part will assess the safety and tolerability of this regimen and gather preliminary data on its biological effects. The third part of the trial will compare the safety and efficacy of selected doses of the peanut SLIT-tablet to a placebo. This trial represents a significant step in ALK's clinical development of a novel food allergy treatment using technology similar to its SLIT tablets for respiratory allergies.