On 18 March 2019, Allergy Therapeutics announced that its Phase III pivotal trial for Pollinex Quattro (PQ) Birch, an ultra-short course birch pollen allergen immunotherapy, failed to meet the primary endpoint of a statistically significant difference between active and placebo arms in the combined symptom and medication score (CSMS) averaged over peak birch pollen season.
Rose Joachim, Pharma Analyst at GlobalData, a leading data and analytics company, offers her view on the effects that this trial failure might have on Allergy Therapeutics plans for US expansion.
“Although this specific PQ product was only being evaluated for approval in the EU, GlobalData expects that the PQ Birch trial failure might also have repercussions on the company’s efforts to expand the product line to the US.
“The failure of the PQ Birch trial puts Allergy Therapeutics in a precarious position. Now the company’s goals of expanding the PQ franchise into the US rely completely on the success of its upcoming Phase III PQ Grass trial, which is set to begin in the EU and US in H2 2019. If the results from the PQ Grass trial also prove to be negative, it is unlikely that the company would pursue lifting the FDA clinical hold on its other two PQ products – PQ Trees (contains birch, alder, and hazel pollens) and PQ Ragweed.
“The only exception could be PQ Ragweed, which has official market authorization in Canada that could serve as a basis for the continued development of the drug in the US. Otherwise, a Phase III failure for PQ Grass would likely mark the end of Allergy Therapeutics’ aspirations of entering the US market.”