Date: 2017-03-16
Type of
information: Recruitment of the first patient
phase: 3
Announcement: recruitment of the first patient
Company: Allergy Therapeutics (UK)
Product: Pollinex® Quattro Birch
Action
mechanism:
- immunotherapy product. Pollinex Quattro is an allergen-specific immunotherapy that comprises three key technologies tailored to reduce irritation and systemic reactions; modified allergens, microcrystalline tyrosine (MCT) and Monophosphoryl lipid A (MPL).
The ultra-short duration of Pollinex Quattro is achieved via allergen modification that transforms the structure of allergens to allow increased doses to be delivered compared to traditional unmodified preparations. The potent depot adjuvant, MCT, has a Th1 immunomodulating 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.
Disease: birch pollen induced seasonal allergic rhinitis
Therapeutic
area: Allergic diseases
Country: Austria, Germany, Poland, Sweden
Trial
details:
Latest
news:
- • On March 16, 2017, Allergy Therapeutics announced 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.
Is
general: Yes
