Stallergenes Greer has initiated a Phase III clinical study of Staloral Birch to treat children and adolescents with birch pollen-induced allergic rhino-conjunctivitis with or without asthma.
Titled ‘YOung patients and BIrch allergy’ (YOBI), the placebo-controlled, randomised, double-blind study will assess the safety and efficacy of Staloral Birch.
It will involve nearly 80 sites in 12 European countries.
Stallergenes Greer CEO Michele Antonelli said: “Stallergenes Greer’s AIT treatments have proven their efficacy and safety in both clinical trials and the real world.
“This paediatric Phase III study illustrates our determination to further develop evidence-based solutions and build on robust datasets and cutting-edge research technologies to advance precision medicine combined with dose adaptation for the benefit of patients with allergies, the medical community, and health systems.”
Staloral Birch, a sublingual solution of allergen extracts for allergen immunotherapy (AIT), is used to treat seasonal or perennial allergic rhinitis, mild to moderate allergic asthma in adults and in some territories, in the paediatric population aged over five years.
Stallergenes Greer’s real-world studies for allergic rhino-conjunctivitis include EfficAPSI and Bringing Real-World Evidence to Allergy Treatment for Health (BREATH).
AIT is the only treatment available to slow the worsening symptoms of allergy. It is administered sublingually thereby providing a needle-free and flexible treatment.