A phase 2 trial of Allergy Therapeutics’ grass pollen candidate met its primary endpoint of showing a dose-response relationship. With the trial also establishing a recommended dose of the short-course subcutaneous allergen-specific immunotherapy, Allergy is set to move into phase 3 next year.
Sites in Europe enrolled 447 patients in the clinical trial and randomized them to receive one of four treatment regimens or placebo. Investigators assessed the effect of the regimens by performing a conjunctival provocation test and monitoring the change in allergic symptoms. That showed a relationship between dose and response, the p value for which was less than 0.0001.
The dose-response primary endpoint was one of two important findings from the trial. The other was the establishment of a dose to take into phase 3.
Allergy had looked set to move into phase 3 two years ago only for its mid-stage study to fail to yield a recommended dose. That setback forced Allergy to run another midphase trial, killing its hopes of getting the product to market in 2020 and raising questions about the future of a candidate that has had more downs than ups. The prospect was on clinical hold from 2007 to 2012.
After stuttering forward for most of the past decade, Allergy can now look forward to getting its grass pollen allergy candidate into a late-phase trial. The progress moves Allergy toward its goal of securing European registration for a grass allergy product, while also advancing its U.S. strategy.
“This brings us closer towards marketing authorization in the estimated $2 billion U.S. allergy market, a significant opportunity where our product has the potential to be the first registered subcutaneous immunotherapy for the treatment of grass allergy,” Allergy CEO Manuel Llobet said in a statement.
Shares in Allergy climbed 12% following the release of the results.