Setback for Allergy’s birch pollen immunotherapy

The Phase III B301 study did not show a statistically significant difference on the primary endpoint - symptom medication score over the peak birch pollen season - between patients receiving Allergy’s drug and those taking a placebo.

On the plus side, the safety and tolerability profile was found to be "positive and consistent" with that observed in previous trials, the group noted.

Also, secondary endpoint analyses of immunoglobulin markers including IgG and IgG4 showed "highly statistically significant differences between active and placebo, suggesting a strong and sustained immune response to treatment," Allergy stressed.

"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, Allergy’s chief executive, commenting on the findings.

The firm said it would now undertake a review of the full dataset to determine the path forward with the product.

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