UK-based Allergy Therapeutics has announced that its new adjuvanted allergoid product indicated for birch pollen-induced seasonal allergic rhinitis failed to meet the primary endpoint in the Phase III B301 trial.
In the multi-centre, double-blind, placebo-controlled study, the drug failed to show a statistically significant reduction in combined symptom medication score averaged over the peak birch pollen season compared to placebo.
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However, the company noted that the drug met its secondary immunoglobin-based endpoints – IgG and IgG4 showed large statistically significant differences between the drug and placebo group. Also, the safety and tolerability profile of the birch allergy product was consistent with previous trials.
Allergy Therapeutics CEO 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.”
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By GlobalDataIn two Phase II trials, the company recorded a 32% reduction in allergic symptoms between the drug and placebo groups.
Allergy Therapeutics creates aluminium-free vaccines and drugs primarily indicated for pollen-related allergies to grass, weeds and trees.
It has taken five products to major global markets, including three Polinex products for pollen allergies and two Venomil products for insect allergies.
Alongside the birch product, the company is undertaking Phase III studies into two other grass and weed products, as well as studying another similar one for tree pollen allergies in Phase I. It is investigating further diagnostics for mites and peanut allergies.
