Allergy Therapeutics’ adjuvanted birch allergoid drug shocks with Phase 3 failure
pharmafile | March 18, 2019 | News story | Research and Development, Sales and Marketing | allergy, allergy therapeutics, pharma, trial failure
UK-based biotech firm Allergy Therapeutics has been left disappointed after it became evident that its adjuvanted birch allergoid product failed its primary endpoint in the treatment of birch-pollen induced seasonal allergic rhinitis.
Newly revealed Phase 3 data indicated that the drug “did not show a statistically significant difference between active and placebo arms”, with trial participants failing to achieve an adequate combined symptom medication score averaged over the peak birch pollen season.
However, the company did note that analyses of the secondary endpoint of immunoglobulin markers including IgG and IgG4 indicated “highly statistically significant differences” between the drug and placebo, suggesting “a strong and sustained immune response to treatment”. The study drew data from 582 patients over 59 centres in Germany, Poland, Austria and Sweden.
The Phase 3 findings are somewhat unexpected considering previous successful Phase 2 results showing that use of the drug led to a 32% reduction in allergic symptoms compared to placebo.
“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,” remarked Manuel Llobet, CEO 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.”
Matt Fellows
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