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.
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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.