Biomay AG reports positive Phase IIb data with the innovative 3rd generation grass pollen allergy vaccine BM32 (28 Jan. 2015)

Biomay, a global leader in allergy immunotherapy, announced today that a landmark phase IIb study ( identifier NCT1538979) has been successfully completed with its 3rd generation grass pollen allergy vaccine BM32. The study was designed to show sustained alleviation of allergy symptoms over two consecutive grass pollen seasons.

It was observed that the Rhinoconjunctivitis Symptom Score (RSS) during the peak pollen season in the second treatment year was reduced by 25% compared to placebo (p=0.042, statistically significant). The treatment also significantly improved patients' well being measured by two independent methods (Visual Analog Scale (VAS, p=0.014) and the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ, p<0.005). A 22% difference of a Combined Symptom and Medication Score (SMS) to placebo was also found (p=0.085). The observed clinical effects were supported by a potent and sustained induction of allergen specific IgG antibodies, which are responsible for blocking the interaction of allergens with IgE on effector cells. Unlike the established allergy vaccines derived from grass pollen extracts, BM32 did not lead to any boost of disease causing IgE production.

The treatment was safe and very well tolerated. Most side-effects were mild to moderate and resolved within a short period after drug application.

In this placebo-controlled, double-blind, prospective study, 181 patients were included and initially received either of two doses of BM32 or a matching placebo. The study was coordinated by Prof. Johannes Ring (Klinik am Biederstein, Technical University of Munich, Germany); 11 trial centers in Austria, Germany, Denmark, Belgium, the Netherlands and Slovenia participated. Before the 2013 grass pollen season, patients received 3 subcutaneous injections over a period of 2 months, followed by a fall boost injection and 3 additional doses before the 2014 season. An independent data management committee (DMC) recommended that all actively treated patients should receive the lower dose (20µg of each of the four protein components) after a review of the data collected in the first treatment year. 141 patients completed all trial procedures.

Rainer Henning, CEO of Biomay commented: "We are very excited that we now have achieved clinical proof of concept with our most advanced product BM32. Not only does BM32 represent the first ever rationally designed grass pollen allergy vaccine, the results of the trial also provide a clear validation of our peptide carrier fusion protein vaccine platform. Following consultation with regulatory authorities we are now planning to move BM32 into phase III registration trials as rapidly as possible, in order to make this innovative product available to patients suffering from grass pollen allergy. In addition, we will move our pipeline products for house dust mite, ragweed, birch pollen and cat dander allergies into clinical development with great confidence."

The complete data set obtained in this trial will be presented in due course at an international conference and will be published in a leading peer reviewed journal in the field of allergy and immunology.



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