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Top Line Phase III results from B301 trial
Top Line Phase III results from B301 trial.
About this update from Allergy Therapeutics Plc
[{"type":"text","content":"\n \nRNS Number : 0975T Allergy Therapeutics PLC 18 March 2019 \n\n \n \n \nAllergy Therapeutics plc\n(\"Allergy Therapeutics\" or the \"Group\")\n \n \nAllergy Therapeutics announces top-line Phase III results from its B301\nclinical trial \n \n- Study primary endpoint not achieved -\n \n- Highly statistically significant and relevant increase in immune response\nobserved in active group compared to placebo -\n \n- Clinical development programme to continue after review of the full dataset -\n \n \n18 March 2019 Allergy Therapeutics plc (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today announced top-line results from the Phase III clinical trial B301of its new adjuvanted birch allergoid product. The trial did not show a statistically significant difference between active and placebo arms in the primary endpoint of a combined symptom medication score averaged over the peak birch pollen season. The safety and tolerability profile was positive and consistent with that observed in previous trials. Importantly, secondary endpoint analyses of immunoglobulin markers including IgG and IgG4 showed highly statistically significant differences between active and placebo, suggesting a strong and sustained immune response to treatment (p <0.0001). \n \n \nManuel Llobet, CEO at Allergy Therapeutics, stated: \"We are surprised by the result, given the strong immune response suggested by the increased immunoglobulin markers in the treatment arm and the substantial symptom improvement we had observed in earlier trials. We will now undertake a comprehensive review of the full dataset to determine our path forward with the investigational product. As a science-driven company we are conscious at Allergy Therapeutics of the challenges regarding subjective measures in allergy field studies. We are committed to overcoming these challenges and bringing this new product to market.\" \n \nAllergy Therapeutics has extensive experience with other approved and commercialized birch products. Since 2010, the investigational product has undergone two successful Phase II trials where a highly statistically significant 32% reduction in allergic symptoms between the active and placebo was observed. The Group will undertake ...