ALK's pivotal Phase 3 trial, MT-12, evaluating the efficacy and safety of its house dust mite sublingual allergy immunotherapy tablet (SLIT-tablet) in children aged 5-11 years with house dust mite allergic rhinitis, has been published in The Lancet Regional Health – Europe. The publication signifies the trial's rigorous peer review and adherence to high scientific standards, marking a significant recognition within the scientific community.
The MT-12 trial, a randomized, double-blind, placebo-controlled study, enrolled 1460 children across 95 sites in Europe and North America between October 2019 and April 2023. Participants received either the house dust mite SLIT-tablet or a placebo daily for one year. The primary objective was to demonstrate the efficacy of the SLIT-tablet compared to placebo based on the total combined rhinitis symptom and medication use during the primary efficacy assessment period.
Key Findings and Clinical Significance
The trial results confirm earlier findings from ALK's adult house dust mite tablet trials, reinforcing the potential of early intervention in managing allergies. This study represents the largest pediatric, randomized controlled trial conducted to date with house dust mite allergy immunotherapy, underscoring its importance in expanding the evidence base for allergy immunotherapy in children.
Henriette Mersebach, Executive Vice President of Research & Development at ALK, emphasized the global impact of respiratory allergies in the younger population, stating, "The MT-12 publication in The Lancet Regional Health – Europe highlights important new paediatric phase 3 data for the house dust mite SLIT-tablet and is essential for expanding the evidence of allergy immunotherapy to help more children live better lives by reducing the burden of allergy in the future."
Broader Context and Market Availability
The house dust mite SLIT-tablet is currently marketed as ACARIZAX® in Europe and various international markets, as ODACTRA® in the USA, and as MITICURE™ in Japan. While Japan has approved MITICURE™ for young children, other markets have approved it for patients aged 12-65 with persistent moderate-to-severe house dust mite-induced allergic rhinitis. In Europe, the tablet is also approved for house dust mite-induced allergic asthma in patients aged 18-65.
Regulatory processes are underway to secure approvals for the house dust mite and tree SLIT-tablets for children in Europe and North America, with potential indications becoming available in 2024/2025, subject to approval.
Additional Trial Data
ALK also reported the publication of results from another Phase 3 children trial, TT-06, in the journal Allergy. This trial evaluated the efficacy and safety of the tree SLIT-tablet in children (5-17 years) with tree pollen-induced allergic rhinoconjunctivitis. With these two trials, ALK and Japanese partner, Torii have completed a total of 14 phase 3 children trials with the SLIT-tablets enrolling paediatric populations with respiratory allergy induced by grass, ragweed, tree and Japanese cedar pollen, and house dust mites.
The MT-12 trial's secondary objectives included demonstrating efficacy based on rhinitis symptoms, rhinitis medication use, combined rhinoconjunctivitis symptoms and medication use, quality of life, and evaluating safety and tolerability. The TT-06 trial's primary objective was to demonstrate efficacy of the tree sublingual tablet compared to placebo based on total combined rhinoconjunctivitis symptom and medication use during the birch pollen season.
