Allergy Therapeutics had pitched 2019 as a pivotal year for its product pipeline, but has suffered a setback before the first quarter has come to an end.
The UK biotech said this morning that the phase 3 B301 trial of its birch pollen allergy product failed to meet its primary objective, with no difference between the immunotherapy and placebo on a combined symptom and medication score, which was averaged over the peak birch pollen season.
The trial started in 2017 and was designed to test the efficacy of the Pollinex Quattro Birch on the symptoms of allergic rhino-conjunctivitis due to birch pollen, as well as its safety.
Biomarkers (including immunoglobulin G and G4) did show a statistically significant improvement over placebo however, and Allergy chief executive Manuel Llobet said the company was “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.”
Two phase 2 studies revealed a significant 32% reduction in allergic symptoms with Pollinex Quattro Birch, a six injection, subcutaneous allergen-specific immunotherapy that gives escalating doses of allergen in order to induce immune tolerance.
At the moment it’s not clear what went wrong in the study and, as uncertainty is never a hit with investors, shares in Allergy went into a steep decline this morning and were down around 43% at the time of writing.
The miss comes as Allergy is preparing for important new trials of product candidates in the coming months, including a pivotal phase III of a grass pollen product that could be the first product of its kind in the $2bn US allergy market and a phase 1 peanut allergy candidate.
Llobet said that the company will now undertake a comprehensive review of the birch pollen dataset and while Allergy is “conscious…of the challenges regarding subjective measures in allergy field studies,” reiterated his determination to bring the product to market.
The news comes shortly after Allergy reported a near-11% increase in interim revenues to £47m (around $62m) which came mainly from its portfolio of tree pollen and house dust mite products.