Stallergenes Greer Announces Positive Phase IIIb Results for Staloral® Birch in Pediatric Patients with Birch pollen Allergy
BAAR, Suisse–(BUSINESS WIRE)–Stallergenes Greer, a world leader in allergy treatment, today announced its Phase IIIb clinical study (YOBI, YOung patients and BIrch allergy) successfully met its primary endpoint. The study confirmed the safety and effectiveness of Staloral® Birch in children and adolescents (ages 5-17) suffering from moderate to severe allergic rhinoconjunctivitis (ARC) triggered by birch pollen, with or without asthma.
The YOBI trial involved 553 patients across 64 centers in 12 European countries.Participants received a daily maintenance dose of 300 IR of Staloral® Birch, administered via a pre-co-seasonal protocol over two consecutive birch pollen seasons.
Results demonstrated a 41% betterment in the combined total RCA score compared to placebo during the second pollen season (p < 0.0001), a statistically and clinically relevant difference of -2.62 points.A statistically meaningful difference (-0.41, p < 0.0001) was also observed in the combined symptom and symptomatic treatment use score,a secondary endpoint recommended by the European Academy of Allergology and Clinical Immunology (EAACI)1.Similar significant and relevant results were seen in the first pollen season. The study confirmed Staloral® Birch’s established safety and tolerability profile.”The positive results of the YOBI study represent a major advance in the expansion of evidence-based allergen immunotherapy to the pediatric population,” said Oliver Pfaar, International Coordinator of the YOBI study and Head of rhinology and Allergology, Department of Otolaryngology, Philipps University Marburg (Germany). “They underline the importance of early treatment and broaden the therapeutic options available to doctors and their patients.”
Dr.elena Rizova, Medical Director of Stallergenes Greer, added, “The results of this major clinical study provide a positive conclusion to the pediatric growth of Staloral® Birch in the treatment of respiratory allergies. They confirm the benefits of treating respiratory allergies with Staloral® Birch from the age of 5, mark an crucial milestone for stallergenes Greer, and strengthen the evidence of the effectiveness of the laboratory’s sublingual liquid treatments.They will also contribute to its geographic expansion. This success underlines Stallergenes Greer’s desire to offer innovative therapeutic options, enabling doctors to better meet the needs of their patients.”
The study results will be presented at an upcoming scientific conference.