18th Mar 2019 10:06
LONDON (Alliance News) - Allergy Therapeutics PLC on Monday said a phase three trial of its birch pollen allergy vaccine did not meet its primary endpoint.
Shares in Allergy Therapeutics were down 43% at 8.16 pence on Monday morning.
The B301 trial found no statistically significant difference between the vaccine and the placebo in terms of a combined symptom medication score, which was averaged over the peak birch pollen season.
However, the secondary endpoint analyses of immunoglobin markers did find "highly statistically significant differences" between the placebo and the genuine vaccine, which Allergy Therapeutics said suggested "a strong and sustained immune response to treatment".
Allergy Therapeutics Chief Executive Manuel Llobet said: "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."
The trial was double-blind, meaning that neither the researchers nor the patients know if the placebo or the real vaccine were administered, and was designed to test the efficacy of the vaccine in birch-pollen induced seasonal allergic rhinitis. In total, 582 patients were enrolled into the study.
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