Danish allergy immunotherapy specialist ALK Abello (ALKB: DC) today announced positive top-line results from a Phase III pediatric clinical trial of its sublingual allergy immunotherapy tablet for the treatment of tree-pollen-induced allergic rhinoconjunctivitis. ALK’s shares rose almost 6% to 85.45 kroner on the news
The tree tablet is marketed as Itulazax in Europe, following approval in 2019, and as Itulatek in Canada, where it was approved in 2020, for patients aged 18 to 65.
ALK noted that the trial achieved its primary endpoint and confirmed the effect of the tree tablet with an improvement of 22% in the total combined rhinoconjunctivitis 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).
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