June has been a bad month for British allergy biotechs. First, Circassia (LON:CIR) came up short in a Phase III cat allergy trial. Now, Allergy Therapeutics (LON:AGY) has reported it failed to determine the recommended dose in Phase II, forcing it to run another study and delaying the date at which it can start a pivotal study of its grass pollen allergy product.
Worthing, U.K.-based Allergy Therapeutics revealed the setback after analyzing the results from a Phase II dose-ranging trial it ran to support the U.S. development of GrassMATAMPL, a short course subcutaneous allergen specific immunotherapy. The trial was designed to build on an earlier Phase II trial 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.
The outcome has left Allergy Therapeutics without a dose regime to advance into Phase III. As such, the start of the pivotal trial has been delayed until Allergy Therapeutics can run another dose range finding study. The second dose range finding clinical trial will employ the same design as a European study of Pollinex Quattro Birch that generated a clear result for Allergy Therapeutics. Specifically, the study will use the conjunctival provocation test, a way of assessing ocular responses to allergens that the company employed when advancing its Pollinex tree pollen product through the clinic and onto the market.
Allergy Therapeutics expects to start the next dose range finding trial in 2017. Before then, the company will meet with the FDA to discuss data from the trial that reported its top-line findings this week. Allergy Therapeutics had hoped that its end-of-Phase II meeting would give it a clear path into a pivotal trial, but it will now need additional dosing data. Prior to the setback, Allergy Therapeutics had aimed to start a Phase III trial later this year, a timeline that would have positioned it to come to market in 2020.
The expectation at Allergy Therapeutics is that it will come to market later than forecast--assuming it makes it that far--but will still be the first company to introduce a subcutaneous allergen specific immunotherapy in the U.S..
Allergy Therapeutics is used to such setbacks. The FDA put the grass product under clinical hold in 2007 after a trial subject reported numbness and weakness. And, with the FDA fearing the symptoms were due to an adjuvant, it kept the clinical hold in place until 2012. Since then, Allergy Therapeutics has raised money and tried to get back on track.
In comparison to the clinical hold, the latest setback could be a fairly minor blow. But on Monday morning, with post-Brexit panic in full flow, investors were in no mood to look for reasons to be cheerful. Shares in Allergy Therapeutics traded down 20% when the market opened.
- read the statement