Stallergenes Greer announced that its Phase IIIb clinical study (YOBI, YOung patients and BIrch allergy) has successfully achieved its primary endpoint, demonstrating the safety and efficacy of Staloral Birch in children and adolescents with birch pollen-induced allergic rhinoconjunctivitis (ARC), with or without asthma.
Study Design and Results
The YOBI trial enrolled 553 children aged 5-17 years with moderate to severe birch pollen-induced ARC across 64 sites in 12 European countries. The study assessed the efficacy and safety of Staloral birch 300IR daily maintenance dose administered pre-and co-seasonally over two consecutive birch pollen seasons.
The study successfully met its primary endpoint, demonstrating a 41% improvement in the ARC total combined score during the second pollen season compared to placebo. These results were highly statistically significant (p<0.0001) and clinically meaningful with a between-group difference of -2.62 points.
The trial also showed highly statistically significant results for its secondary endpoint, with a difference of -0.41 (p<0.0001) when using the combined symptom and medication score recommended by the European Academy of Allergy and Clinical Immunology (EAACI). Similar statistically significant and clinically relevant results were observed during the first pollen season.
Safety Profile
Safety and tolerability observed in the YOBI study were consistent with the established safety profile of Staloral Birch, according to the company's announcement.
Clinical Significance
"The positive results of the YOBI study represent a significant advancement in extending evidence-based allergen immunotherapy to the paediatric population. They highlight the importance of early intervention and broaden treatment options for physicians and their patients," declared Oliver Pfaar, International Coordinator of the YOBI study and Chair of the section of Rhinology and Allergy, Department of Otorhinolaryngology, Philipps-Universität Marburg, Germany.
Dr. Elena Rizova, Chief Medical Officer at Stallergenes Greer, stated that "The positive outcome of this large clinical study successfully completes our paediatric development of Staloral Birch in respiratory allergies. The results, which confirm the benefits of treating respiratory allergies with Staloral Birch from early childhood, mark a significant milestone for Stallergenes Greer."
Disease Burden and Treatment Context
Allergic rhinoconjunctivitis affects more than 500 million people worldwide and represents a global health burden. Patients with this condition are at higher risk of developing rhinitis exacerbation and asthma than the general population. Birch is among the strongest allergy-producing trees in northern Europe, with the allergic potential of other trees in the birch homologous group, such as alder and hazel, also increasing steadily.
In children and adolescents, allergic rhinoconjunctivitis can lead to sleep problems, fatigue, missed school days and can complicate outdoor activities. Individuals sensitized at a young age are at higher risk of developing asthma, with younger children facing the highest risk. This highlights the relevance of early causal treatment in pediatric patients to slow the worsening of allergy symptoms.
Allergen immunotherapy (AIT) is currently the only available therapeutic treatment that has the potential to uniquely alter the natural course of the disease. In its liquid form, sublingual AIT can provide a needle-free and flexible treatment for children and adolescents.
About Staloral
Staloral is a sublingual solution of allergen extracts for allergen immunotherapy that covers a broad spectrum of allergens, including pollen, house dust mites, and animal dander. Clinical evidence of Staloral's efficacy has been demonstrated consistently across clinical studies conducted by Stallergenes Greer versus placebo.
Staloral Birch is currently commercialized in 21 countries, in accordance with the regulatory status of each country. Study results from the YOBI trial will be submitted for presentation at an upcoming major scientific congress meeting.
