The year-long study over 50 sites in Germany, Sweden, Austria and Poland will recruit 550 patients and assess the efficacy and safety of its ultra-short course treatment Pollinex Quattro.
A successful outcome will pave the way to marketing authorisation in 2019.
"The start of our phase III trial investigating Pollinex Quattro Birch marks the beginning of a number of trials aimed at strengthening our product portfolio across Europe and helping the 6% of Europeans who test positive to birch allergens,” said chief executive Manuel Llobet.
If approved, Pollinex Quattro Birch will be the first MPL enhanced ultra-short course aluminium-free vaccine ever approved.
MPL, or monophosphoryl lipid A, is what’s called an adjuvant that enhances the body’s immune response.
“Combined with our clinical programme in the US focusing on Pollinex Quattro Grass, we aim to have a comprehensive global modified allergen + MCT and MPL vaccine package that focuses on delivering convenience, safety, efficacy and enhanced patient compliance," said Llobet.