|Allergy Therapeutics CEO Manuel Llobet|
U.K.-based Allergy Therapeutics is finally kicking off Phase II trials of its grass allergy vaccine in the U.S, announcing Monday that it has recruited its first trial participants. The trial will be a double-blind, placebo-controlled, cumulative dose selection study, according to Proactiveinvestors.
While the company remains optimistic, expecting data in Q2 2016 and planning to submit the candidate for FDA approval at the end of 2018, the candidate has seen its fair share of speed bumps. The vaccine, known as Pollinex Quattro Grass, has been available in Europe for some years, but has faced regulatory hurdles in the U.S.
It was hit with an FDA hold in 2007 after a trial volunteer suffered adverse effects--numbness and weakness--during a trial. The FDA freeze triggered a 22% drop in the company's share price. The hold wasn't lifted until 2012, at which point Allergy Therapeutics began seeking partners to help advance the candidate into Phase III. But it wasn't until three years later that the British company scored funding to propel it forward.
In March this year, Allergy Therapeutics sought £20 million ($30 million) from public investors with an equity issue. With the funding, the company said it would navigate the subcutaneous allergy vaccine through FDA-requested studies. These include a patient registry study and an exposure chamber Phase III efficacy trial, which will expose participants to allergens.
Although the candidate has been delayed for years, Allergy Therapeutics hopes it's on schedule to bring the jab to market in 2019.
"We have the opportunity to be the first FDA-licensed seasonal subcutaneous immunotherapy allergy vaccine, and so access an estimated $2 billion market," Allergy Therapeutics CEO Manuel Llobet said in a March 2015 statement.
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