16 March 2017
Allergy Therapeutics plc: First Patient Recruited in Pivotal Phase III Birch Immunotherapy B301 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.
“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.”
Manuel LlobetChief Executive Officer of Allergy Therapeutics
For further information, please contact:
+44 (0) 1903 845 820
Manuel Llobet, Chief Executive Officer
Nick Wykeman, Finance Director
+44 (0) 20 7886 2500
Freddy Crossley / Duncan Monteith, Corporate Finance
Tom Salvesen, Corporate Broking
Consilium Strategic Communications
+44 20 3709 5700
Mary-Jane Elliott / Ivar Milligan
Notes for editors:
About Allergy Therapeutics
Allergy Therapeutics is an international specialty pharmaceutical company focussed on the treatment and diagnosis of allergic disorders including immunotherapy vaccines that cure disease. The Company sells proprietary products and third party products from its subsidiaries in nine major European countries and via distribution agreements in an additional ten countries.
Formed in 1999 out of Smith Kline Beecham, Allergy Therapeutics is headquartered in Worthing, UK with MHRA-approved manufacturing facilities. The Company employs c.495 employees and is listed on the London Stock Exchange (AIM:AGY). For more information, please see www.allergytherapeutics.com.
About Pollinex Quattro Birch
Pollinex Quattro Birch is a unique ultra-short course allergen-specific immunotherapy comprising three key technologies tailored to reduce irritation and systemic reactions, namely: modified allergens, microcrystalline tyrosine (MCT®) and monophosphoryl lipid A (MPL).
The ultra-short duration of treatment is achieved via allergen modification that transforms the structure of birch allergens to allow increased doses to be delivered compared to traditional unmodified preparations. The potent depot adjuvant, MCT®, has a Th1 immuno-modulating action that acts in synergy with the TLR4 receptor agonist MPL to augment a shift in the immune reactions responsible for the symptoms of allergic rhinitis.
About Allergic Rhinitis
Allergic rhinitis and conjunctivitis affects between 10% and 30% of the population worldwide1. Symptoms can be intrusive and debilitating and can include watery eyes, runny nose and inflammation. Current first line treatments such as antihistamines and corticosteroids lead to insufficient symptom control and add to the economic and patient burden. Currently, specific immunotherapy is the only known treatment that addresses the underlying cause of symptoms.
World Health Organization. White Book on Allergy 2011-2012 Executive Summary. By Prof. Ruby Pawankar, MD, PhD, Prof. Giorgio Walkter Canonica, MD, Prof. Stephen T. Holgate, BSc, MD, DSc, FMed Sci and Prof. Richard F. Lockey, MD.