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Allergy Therapeutics surprised by the results of PQ Birch jab trial

The B301 trial was a multi-centre, double-blind, placebo-controlled study designed to test the efficacy in birch-pollen induced seasonal allergic rhinitis
Birch trees
The group will undertake a review of the full trial dataset to understand any cause for the lack of consistency in the clinical outcomes seen between the studies

Allergy Therapeutics PLC (LON:AGY) received a setback as top-line results from the Phase III clinical trial of its new adjuvanted birch allergoid product disappointed.

The profitable drugs development company said the trial did not show a statistically significant difference between those taking the drug and those receiving the placebo.

READ: Allergy Therapeutics sees first-half sales, profits jump ahead of “pivotal” year

The safety and tolerability profile was positive and consistent with that observed in previous trials and the company stressed that secondary endpoint analyses of immunoglobulin markers, including the IgG and IgG4 sub-class results, showed highly statistically significant differences between active and placebo, suggesting a strong and sustained immune response to treatment.

"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,” said Manuel Llobet, the chief executive officer at Allergy Therapeutics.

“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," he added.

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