Company News: Anergis Completes Patient Recruitment in Large-Scale ATIBAR Trial with Ultra-Fast Allergy Immunotherapy AllerT
— 421 patients randomized at 38 European trial centers
— Top-line results expected in Q3, 2017
Anergis, a company developing proprietary ultra-fast allergy immunotherapy, announced today that it has completed patient recruitment in the ATIBAR trial, a Phase IIb field-based clinical trial with Anergis’ lead compound AllerT for patients with birch pollen allergy.
421 patients were randomized at 38 European trial centers in Denmark, Finland, Germany, Lithuania, Norway, Poland, Slovakia and Sweden between September 2016 and January 2017. The study is designed to assess the efficacy and tolerability of two dosing regimens of AllerT In Adults with Birch Pollen Allergic Rhinitis/Rhinoconjunctivitis (ATIBAR). Patients with moderate to severe allergy to birch pollen were randomly allocated to receive one of three double-blind treatments administered as 5 subcutaneous injections over 2 months: placebo, AllerT 50 µg or AllerT 10 µg. ATIBAR is the largest field-based trial conducted so far with an ultra-fast allergy treatment for tree pollen allergy.
The ATIBAR trial was designed as a confirmatory efficacy trial with efficacy endpoints and the statistical power required to meet both European and US FDA efficacy criteria for registration trials in allergy immunotherapy. Its primary efficacy endpoint is a combined symptom and medication score assessed daily in natural conditions during birch pollen season, based on the recommendations of the European Association of Allergy and Clinical Immunology (Allergy 2014, 69, 854-67).
Top-line ATIBAR trial results are expected in the third quarter of 2017.