ALK’s sublingual allergy immunotherapy tablet was found to be effective in pediatric patients with house dust mite (HDM)-induced allergic rhinitis, according to phase 3 trial results.
The study (ClinicalTrials.gov Identifier: NCT04145219) included 1458 children aged 5 to 11 years with a clinical history of HDM-induced allergic rhinitis with or without conjunctivitis (and with or without asthma). Study participants were randomly assigned to receive 1 sublingual allergy immunotherapy tablet (Odactra) daily or placebo. The primary endpoint was the change in combined rhinitis symptoms and medication use during the last 8 weeks of the 12-month treatment period.
Results showed that patients treated with the sublingual allergy immunotherapy tablet had a 22% improvement in the total combined rhinitis score compared with placebo (P <.0001). All key secondary endpoints were also met, according to the Company.
“The successful and unprecedented outcome of the trial will allow us to make a valuable difference for the many children living with house dust mite allergy,” said ALK’s Executive Vice President of Research and Development, Henriette Mersebach. “The results are very robust and consistent with previous trial results, and clearly confirm the benefits of treating childhood allergies with our tablets.”
Odactra is currently approved for the treatment of HDM-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or positive skin testing to licensed house dust mite allergen extracts in patients 12 years of age and older. Based on these trial results, the Company is expected to pursue an expansion of the product indication with regulatory authorities.
Large phase 3 clinical trial successfully meets primary endpoint, confirming the potential of ALK’s house dust mite tablet in young children. ALK. News release. June 8, 2023. https://www.globenewswire.com/news-release/2023/06/08/2684928/0/en/Large-Phase-3-clinical-trial-successfully-meets-primary-endpoint-confirming-the-potential-of-ALK-s-house-dust-mite-tablet-in-young-children.html.