It was observed that the Rhinoconjunctivitis Symptom Score (SS) during the peak pollen season in the second treatment year was reduced by 25% compared to the placebo (p=0.042, statistically significant). The treatment also significantly improved patients’ well-being measured by two independent methods (Visual Analogue 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 the 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 the matching placebo. The study was coordinated by Prof. Johannes Ring (Klinik am Biederstein, Technical University 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 (20 µg of each of the 4 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.
About BM32 and peptide carrier fusion vaccines:
BM32 is an innovative grass pollen allergy vaccine based on recombinant peptide carrier technology invented in the lab of Prof. Rudolf Valenta at the Medical University of Vienna. This is a revolutionary concept, which offers potential for a paradigm shift in the treatment of allergies. The peptide carrier fusion proteins are constructed from the immunogenic viral coat protein PreS of the hepatitis B virus (HBV) and peptides from the IgE binding epitopes of the allergens in question; the latter have been engineered to lose their IgE binding capacity. BM32 has been designed to protect patients from the debilitating effects of grass pollen exposure and possibly provide long term cure. The product is very convenient to use for patients and doctors, as only a very small number of subcutaneous applications is needed to achieve efficient desensitization.
Based on the same technology platform, additional vaccines targeting different allergies (house dust mite, ragweed, birch and cat dander) are in preclinical development and will be advanced to clinical trials in the near future.
Biomay AG is a privately held biopharmaceutical company based in Vienna, Austria. The company is committed to be a leader in the discovery and development of innovative allergy therapeutics. Besides BM32, the company has a pipeline of products for the treatment of other major allergies caused by airborne allergens. www.biomay.com