ALK’s Itulatek, a sublingual allergy immunotherapy tablet, has met its primary endpoint in the Phase III paediatric clinical trial for treating tree-pollen-induced allergic rhinoconjunctivitis.

Itulatek (marketed as Itulazax in Europe) is a standardised allergen extract, which was first approved for the treatment of moderate-to-severe seasonal allergic rhinitis from tree pollen, namely birch, alder and/or hazel. It is approved for use in adult patients aged 18–65 years in Europe and Canada.

In light of the trial meeting its primary endpoint, ALK plans to seek label expansion to include paediatric patients, with an expected paediatric launch in 2025.

“With the outcome of this large clinical trial, we have now successfully completed our paediatric development of all of ALK’s sublingual AIT tablets in respiratory allergies,” said ALK’s executive VP of R&D, Henriette Mersebach.

There has been a renewed interest in developing therapies for treating allergies, including environmental and food allergies. GlobalData forecasts DBV Technologies’ peanut allergy therapy, Viaskin Peanut, to be one of the most profitable drugs in the allergy market, generating global sales of $1.5bn (€1.41bn) by 2030.

GlobalData is the parent company of Clinical Trials Arena.

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Phase III trial data

The placebo-controlled Phase III trial (NCT04878354) enrolled 952 children aged 5–17 years with a history of moderate-to-severe allergic rhinitis induced by birch or associated tree pollen. The participants were evaluated during Canada and Europe’s 2022 and 2023 pollen seasons. 

The trial met its primary endpoint, with a 22% improvement in allergic symptoms compared with placebo during the birch pollen season, measured using total combined rhinoconjunctivitis score (TCS). The Danish company expects to present trial data at a medical conference in 2024.

The study also met a secondary endpoint by showing improvement in TCS with Itulatek during the entire tree pollen season. The therapy was safe and tolerable, with 96% of the patients completing the trial.

Another allergic therapy in ALK’s pipeline is Acarizax for treating house dust mites. The company reported positive Phase III trial data for Acarizax usage in paediatric patients.