ALK announced top-line results from a Phase 3 paediatric clinical trial of its sublingual allergy immunotherapy tablet for the treatment of house dust mite (HDM)-induced allergic rhinitis. The HDM tablet is marketed as ACARIZAX® in Europe and a number of international markets, as ODACTRA® in the USA, and as MITICURE™ in Japan. The trial achieved its primary endpoint with an improvement of 22% in the total combined rhinitis score (TCRS) compared to placebo treated patients.

Results were highly statistically significant (p<0.0001), with a lower bound of the 95%-confidence interval of 12%, versus a threshold criterion of minimum 10% as required by the US Food and Drug Administration (FDA). The trial also demonstrated that the treatment was well tolerated and had a favourable safety profile, similar to the safety profile reported in adolescents and adults. All key secondary endpoints were also met, further confirming the efficacy of the HDM tablet.

The trial was well conducted with more than 95% of patients maintaining treatment throughout the trial. This trial confirms earlier results reported in ALK's adult HDM 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 1,458 children in North America and Europe, was a Phase 3, randomised, placebo-controlled trial to study the efficacy and safety of ALK's HDM tablet in children aged 5 to 11 with a clinical history of HDM-induced allergic rhinitis with or without conjunctivitis (and with or without asthma).

The trial was designed to demonstrate the effect of treatment with the HDM tablet as measured by improvement in allergy symptoms and reduction in allergy pharmacotherapy use during the last eight weeks of the 12-month-treatment. Globally, it is estimated that more than 10 million children, aged 5 to 11, have uncontrolled respiratory allergies and the number is growing. House dust mites are a common cause of allergy and closely linked to asthma.

Japan is currently the only country where the HDM tablet (MITICURE™) is approved for young children, while in other markets it is approved for the treatment of persistent moderate-to-severe HDM-induced allergic rhinitis for patients aged 12-65. In addition, in Europe, the tablet is also approved for HDM-induced allergic asthma in patients aged 18-65. ALK will now pursue a dialogue with relevant regulatory authorities about expanding the current product indications.

Subject to approval, the HDM tablet could be available for young children in Europe and North America in 2024/25. ALK expects to present the further details from the trial at a scientific congress later in 2023/24. In line with ALK's commitment to secure approvals for all of ALK's respiratory tablets covering paediatric, adolescent, and adult use, ALK is also completing a pivotal, Phase 3 paediatric trial with its tree pollen tablet (ITULAZAX®).

ALK expects to report top-line results from this trial in fourth quarter 2023.