Allergy Therapeutics' birch allergoid product fails to hit main goal of late-stage trial

Allergy Therapeutics announced Monday that a Phase III study of its birch allergoid product failed to meet its primary endpoint, with shares in the company plunging as much as 43 percent on the news. CEO Manuel Llobet said "we are surprised by the result," adding "we will now undertake a comprehensive review of the full dataset to determine our path forward with the investigational product."

In the B301 trial, 582 patients with seasonal allergic rhinitis were randomised into active and placebo arms, with the study designed to measure a reduction in allergic symptoms as determined by the combined symptom medication score. However, top-line results showed that there was no significant difference between the two arms in the primary endpoint of a combined symptom medication score averaged over the peak birch pollen season.

Llobet noted that the failure of the study to achieve its main goal came despite "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." Allergy Therapeutics indicated that secondary endpoint analyses of immunoglobulin markers including IgG and IgG4 showed "highly…significant" differences between active and placebo, which it said suggested "a strong and sustained immune response to treatment." 

According to the drugmaker, prior Phase II studies of the birch allergoid product showed a significant 32-percent reduction in allergic symptoms between the active and placebo groups. Allergy Therapeutics said it review all of the data "to understand any cause for the lack of consistency in the clinical outcomes seen between the studies."

Allergy Therapeutics' birch allergoid product is a six injection, subcutaneous allergen-specific immunotherapy designed to treat the cause of allergic rhinitis. The therapy contains three components, a birch allergoid, micro-crystalline tyrosine and monophosphoryl lipid A.

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