Anergis Reports Positive Phase IIb Data for Birch Pollen Allergy Vaccine AllerT
Anergis reported that a Phase IIb study of its lead compound AllerT met the primary endpoint of reducing the combined symptom and medication score with AllerT 50 μg during the birch pollen season. Moreover, the vaccine improved the quality of life and symptom scores with AllerT 50 μg and AllerT 100 μg. AllerT is a birch pollen allergy vaccine derived from the company´s proprietary Contiguous Overlapping Peptide (COP) technology platform, which is designed to provide ultra-fast allergy desensitization after only two months of treatment.
In a placebo-controlled, double-blind, randomized multicenter trial, a total of 240 patients from 24 trial centers in Switzerland, France, Poland, Latvia, Lithuania, Sweden and Denmark were divided into three groups (placebo, AllerT 50 μg and AllerT 100 μg, respectively). From November 2012 to March 2013, the patients received 5 injections over a period of 2 months as a pre-seasonal treatment.
During the subsequent 2013 birch pollen season, compared to the placebo group, the combined Rhinoconjunctivitis Symptom and Medication Score (RSMS, primary endpoint) was reduced by 30% (p=0.024, statistically significant) with AllerT 50 μg and by 19% (p=0.190, not statistically significant) with AllerT 100 μg. Both AllerT doses were associated with similar statistically significant improvements in the total score of the Rhinoconjunctivitis Quality of Life Questionnaire (Mini-RQLQ) and in the rhinoconjunctivitis symptom score throughout the birch pollen season. All other secondary endpoints showed similar efficacy trends.
AllerT was safe and well-tolerated throughout the two-month pre-seasonal treatment. Most adverse events were mild or moderate, resolved within 24 hours, and there were no reports of anaphylactic shock or grade 3 allergic reactions within 30 minutes following any of the injections.
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