Allergy Therapeutics: First Patient in Pivotal Phase III Birch Study
Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces the recruitment of the first patient in its Phase III study designed to evaluate the efficacy and safety of its ultra-short course, aluminium-free Pollinex® Quattro Birch immunotherapy to address the cause of symptoms of allergic rhinoconjunctivitis due to birch pollen.
The first patient in the B301 Phase III study was recruited in Austria on 15 March. The study is anticipated to run for one year and involve more than 550 patients over 50 sites across Germany, Sweden, Austria and Poland. The primary objective of this study is to evaluate the efficacy of Pollinex® Quattro Birch in birch pollen-induced rhinoconjunctivitis and to enable registration of the product in Germany via the Therapieallergene-Verordnung (TAV) process of the Paul Ehrlich Institut, before anticipated marketing authorisation in 2019.
The adopted cumulative dose has been demonstrated to be efficacious in two recent dose range finding studies with respect to reduction of symptoms induced by a conjunctival provocation test (CPT) with no prior safety concerns.
Manuel Llobet, CEO said:
“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. If approved, Pollinex Quattro Birch will be the first MPL adjuvanted ultra-short course aluminium-free vaccine ever approved. 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.”