Allergic rhinoconjunctivitis affects more than 500 million people worldwide, with children facing particular challenges including sleep disruption, missed school days, and increased asthma risk. Stallergenes Greer announced that its Phase IIIb clinical study for Staloral Birch, a sublingual allergen immunotherapy, met its primary endpoint in children and adolescents with birch pollen-induced allergic rhinoconjunctivitis.
Key Points
- The YOBI study enrolled 553 children aged 5-17 years with moderate to severe birch pollen-induced allergic rhinoconjunctivitis, with or without asthma, across 64 sites in 12 European countries. Participants received Staloral Birch 300IR daily maintenance dose administered pre-and co-seasonally over two consecutive birch pollen seasons.
- The study reported a 41% improvement in the allergic rhinoconjunctivitis total combined score during the second pollen season compared to placebo, with a between-group difference of -2.62 points (p<0.0001).
- Staloral Birch is currently sold in 21 countries, in accordance with each country’s regulatory status.
The study adds to the evidence base for treating pediatric birch allergies, with results planned for presentation at an upcoming scientific congress.
The Data
- The trial enrolled 553 children aged 5-17 years with moderate to severe birch pollen-induced allergic rhinoconjunctivitis, with or without asthma, across 64 sites in 12 European countries.
- The primary endpoint showed a 41% improvement. A secondary endpoint using the combined symptom and medication score recommended by the European Academy of Allergy and Clinical Immunology showed a difference of -0.41 (p<0.0001). Similar results were observed during the first pollen season.
- The company characterized these results as statistically significant and clinically meaningful. The observed safety and tolerability were consistent with the product’s established safety profile.
Industry Context
The positive outcome of this large clinical study successfully completes our paediatric development of Staloral Birch in respiratory allergies.
Dr. Elena Rizova, Chief Medical Officer
Allergic rhinoconjunctivitis represents a global health burden, with patients at higher risk of developing asthma compared to the general population. Birch ranks among the stronger allergy-producing trees in northern Europe, and trees in the birch homologous group, including alder and hazel, show steadily increasing allergic potential. In pediatric populations, the condition can lead to sleep problems, fatigue, and missed school days, with children sensitized at younger ages facing elevated asthma risk.
Allergen immunotherapy aims to be the only available therapeutic treatment with the potential to alter the disease’s natural course. The sublingual liquid formulation provides a needle-free administration option for children and adolescents. Stallergenes Greer, headquartered in Switzerland, develops and commercializes allergen immunotherapy products available in over 40 countries, supported by what the company describes as more than 100 years of expertise.
