Anergis Reports Positive Phase IIb Data for Birch Pollen Allergy Vaccine

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12.09.2013

Anergis, a company focusing on proprietary allergy vaccines, reported today 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.

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.

About Anergis
Anergis SA is a Swiss-based biopharmaceutical company specializing in the discovery and development of novel, proprietary allergy vaccines targeting commercially attractive indications. Anergis´ vaccines are based on its IP-protected Contiguous Overlapping Peptide technology. Allergies are the most prevalent and fastest growing chronic conditions in the industrialized world affecting over 500 million people. Anergis’ lead-product AllerT, a vaccine to treat birch pollen allergies, is due to enter Phase III clinical development in 2014.

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