When the FDA lifted a 5-year clinical hold on Allergy Therapeutics’ grass pollen allergy vaccine, CEO Manuel Llobet signaled that the company needed only to “finalize the clinical development” before they can unlock the $2 billion market value waiting for their subcutaneous jab. But investors’ confidence in the whole immunotherapy platform was threatened again Monday after Allergy conceded a top-line failure for another Phase III product protecting against birch pollen.
The vaccine, dubbed Pollinex Quattro Birch or B301, did not make a statistically significant impact on a combined symptom medication score averaged over the peak birch pollen season for 582 patients across Germany, Poland, Austria and Sweden who had hay fever induced by birch.
That’s despite evident elevated presence of immunoglobulin markers such as IgG and IgG4, which indicates a “strong and sustained immune response to treatment” — with p <0.0001 on the differences between active and placebo.
“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,” Llobet said in a statement. “We will now undertake a comprehensive review of the full dataset to determine our path forward with the investigational product.”
The news eviscerated Allergy’s already battered stock price (LON: $AGY), taking 40% — or £0.06 — off per share.
It will now be even more important to prove the Pollinex Quattro tech in the upcoming grass study, which is expected to kick off this year. It’s a project that the UK-based biotech raised £20 million for back in 2015 in pursuit of the lucrative US market, which would add to its modest profit (adding to £16.36 million in 2018).
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