Anergis, a Swiss-based biopharmaceutical company focusing on proprietary allergy vaccines, reported that 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.
“With this study, we have now confirmed the efficacy of AllerT in a real-life, seasonal setting and are very satisfied with its safety profile,” said Vincent Charlon, CEO of Anergis. “We are very confident that the efficacy of AllerT will be long-lasting, based on previously reported long-term antibody responses in our Phase I patients. We are therefore planning to proceed to phase III as soon as possible in order to make AllerT available to allergy patients in the near future. Moreover, the results are very encouraging for the development of our follow-on pipeline products.”
COP vaccines can be applied to a broad variety of allergy indications. Besides AllerT for the treatment of birch pollen allergies, Anergis´ COP allergy vaccine pipeline currently includes AllerR for ragweed pollen allergies and AllerDM for dust mite allergies.