ALK announced top-line results from a Phase 3 paediatric clinical trial of its sublingual allergy immunotherapy tablet for the treatment of tree-pollen-induced allergic rhinoconjunctivitis. The tree tablet is marketed as ITULAZAX®? in Europe and as ITULATEK®?

in Canada for patients aged 18 to 65. The trial achieved its primary endpoint and confirmed the effect of the tree tablet with an improvement of 22% in the total combined rhinoconjjunctivitis score (TCS) during the birch pollen season compared to placebo. Results were highly statistically significant (p=0.0004), with a lower bound of the 95%- confidence interval of 10.6%.

The trial also demonstrated improvement in TCS during the entire tree pollen season (key secondary endpoint). In addition, the trial demonstrated that treatment with the tree tablet was well tolerated and had a favourable safety profile, similar to the safety profile reported in other trials. The trial was well conducted with 96% of patients completing the trial.

This trial confirms previous results reported in ALK's tablet trials and was conducted in accordance with ALK's strategy to focus on children and to treat allergies at an early stage in life. The trial, which involved 952 children in Canada and Europe, was a Phase 3, randomised, placebo-controlled trial to study the efficacy and safety of ALK's tree tablet in children aged 5 to 17 with a clinical history of moderate to severe allergic rhinitis and/or conjunctivitis induced by pollen from birch trees as well as from other trees belonging to the birch homologous group. The trial was designed to confirm the effect of treatment with the tree tablet as measured by improvement in allergy symptoms and reduction in allergy pharmacotherapy use during the 2022 and 2023 pollen seasons.

Globally, it is estimated that more than 10 million children have uncontrolled respiratory allergies, and the number is growing. Tree pollen is a common cause of these uncontrolled allergies. ALK will now pursue a dialogue with relevant regulatory authorities about expanding the current product indications.

Subject to approval, the tree tablet could become available for young patients in Europe and Canada in 2025. ALK expects to present further details from the trial at a scientific congress in 2024. In line with ALK's commitment to secure approvals for all of ALK's respiratory tablets covering paediatric, adolescent, and adult use, ALK has also recently successfully completed a pivotal, Phase 3 paediatric trial with its house dust mite tablet (ACARIZAX®?).