ALK Announces Positive Phase 3 Pediatric Trial Results for Respiratory Allergies

At the Annual Congress of the European Academy of Allergy and Clinical Immunology (EAACI), held in Valencia, Spain, from May 31 to June 3, 2024, ALK—a Danish pharmaceutical company—unveiled significant findings from two pivotal phase 3 clinical trials targeting paediatric patients with respiratory allergies. These trials focused on the efficacy and safety of SQ sublingual immunotherapy (SLIT) tablets for house dust mite (HDM) and tree pollen allergies.

ALK's contributions to the EAACI 2024 scientific program included a total of 18 scientific abstracts. Among these were notable results from the two key paediatric phase 3 trials:

1. MT-12 Trial: This was a placebo-controlled phase 3 study examining the effectiveness and safety of the SQ HDM SLIT-tablet in children aged 5-11 years suffering from HDM-induced allergic rhinitis/rhinoconjunctivitis, with or without asthma.
2. TT-06 Trial: Another placebo-controlled phase 3 trial, this study explored the efficacy and safety of the SQ tree SLIT-tablet in children and adolescents aged 5-17 years. These participants had moderate to severe allergic rhinitis and/or conjunctivitis triggered by birch pollen and other trees in the birch homologous group.

The outcomes of these trials were highlighted in four oral presentations by leading trial investigators at the EAACI Congress. The findings revealed promising results for treating paediatric patients, substantiating the efficacy and safety of SLIT-tablets in mitigating respiratory allergies caused by house dust mites or birch pollen.

An additional platform for discussing these findings was the ALK symposium on June 1, emphasizing the clinical significance of the new data. The paediatric phase 3 results demonstrated a positive impact on children’s daily lives, showing notable reductions in clinical symptoms, decreased medication use, and improved quality of life for young patients with respiratory allergies.

The SLIT-tablets were generally well-tolerated, presenting a safety profile consistent with previous trials. This underscores the importance of early allergy treatment in children and highlights the clinical relevance of developing future therapeutic strategies for this demographic.

Henriette Mersebach, Executive Vice President of Research & Development at ALK, underscored the importance of these findings, stating, "The global impact of respiratory allergies in the younger population underscores our responsibility to address and alleviate the burden of this condition, highlighting the value of generating new paediatric phase 3 data for the SQ SLIT-tablet portfolio of therapeutic solutions. This is an important step towards helping many more children live better lives without the burden of allergy."

Looking forward, ALK has made regulatory submissions for the SQ HDM SLIT-tablet for children aged 5-11 years. Pending approval, these tablets could be available in Europe by late 2024 or early 2025. Similarly, the regulatory filing for the tree SLIT-tablet aims to extend its current indication to include children aged 5-17 years. Subject to approval, this tablet could be available for young patients in Europe and Canada by 2025.

These steps reflect ALK's dedication to advancing allergy treatments and improving the quality of life for individuals affected by respiratory allergies.

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