Allergy Therapeutics saw its stock down by 40% in early trading in London Monday morning after its birch pollen drug failed to move the needle in a key phase 3 trial, though the biotech, no stranger to setbacks, has vowed to keep calm and carry on.
The late-stage test saw its experimental drug, known as B301, fail to show a statistically significant difference between active and placebo arms in the primary endpoint of a combined symptom medication score averaged over the peak birch pollen season.
The was a glimmer of hope in that 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,” the AIM-listed biotech said, though exact details and data were not provided.
The flop has not, however, been enough to scupper development, as U.K.-based Allergy said its clinical development program is set to continue “after review of the full dataset.”
CEO Manuel Llobet was still taken aback by the latest data, saying he and the company were “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.”
Maybe he shouldn’t be too surprised, historically at least, as Allergy has not had the straightest path to this point, which included a mammoth five-year clinical trial hold of its U.S. trial program for Pollinex Quattro Grass, starting in 2007, after a trial participant reported numbness and weakness.
This was eventually lifted in 2012, and in 2015 it got $20 million to move its subcutaneous immunotherapy allergy vaccine through late-phase development. But the year after, it was hit again, this time by weak trial results in a midstage dose-ranging trial it ran to support the U.S. development of the therapy, known as GrassMATAMPL.
The trial was designed to build on an earlier phase 2 that successfully generated dose response data. However, after giving higher doses of the immunotherapy to subjects and exposing them to allergens in mobile environmental exposure chambers, Allergy Therapeutics was left with data that rendered it unable to identify an optimized regime back in the summer of 2016.
It has been getting back on track, and last May saw its grass allergy drug meet its primary endpoint of showing a dose-response relationship, which promptly saw its stock rise.
But these latest birch tree data has seen it shares slump 40% by 9 a.m. London time Monday morning. At the start of the month, the biotech had a cash balance of just under £32 million ($42.4 million).