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Biomay AG reports positive results from a second Phase IIb trial with the innovative 3rd generation grass pollen allergy vaccine BM32 (26 Jan. 2017)
Biomay, a global leader in allergy immunotherapy, announced today that a second phase IIb study (clinicaltrials.gov identifier NCT02643641) has been successfully completed with its third generation grass pollen allergy vaccine BM32. The study was designed to demonstrate the optimal dose regimen to induce an allergen-specific IgG immune response. Correlation of the immunological effects with the alleviation of allergy symptoms in the subsequent grass pollen season was another important objective of the trial.
The study reached its primary endpoint: it was observed that a regimen of five monthly injections of 80μg of BM32 was statistically significantly superior to all other dosing schemes in terms of induction od allergen specific IgG4 (p<0.05 vs. three and four injections; p<0,0001 vs. placebo).
This dose regimen also provided for a statistically significant and clinically meaningful improvement of a combined rhinoconjunctivitis symptom and medication score (SMS) vs. placebo during the peak pollen season (p<0.0001) and the whole pollen season (>100 grains/m3/24hrs, p<0.0001) measured by area under the curve (AUC). Patients' well-being evaluated by visual analog scale (VAS) was significantly improved by 50% during the days with the highest pollen exposure (p<0.05) in this dose group. The effect size of these important endpoints is highly clinical relevant. In a pollen chamber session eight weeks after the grass pollen season, the groups receiving four and five doses of BM32 showed a very clear reduction of nasal sensitivity during a six hour controlled exposure to grass pollen.
As in the previous studies, the treatment was safe and very well tolerated. Most side-effects were local injection site reactions, were mild to moderate and rsolved within a short period after drug application.
In this placebo-controlled, double-blind, prospective study, 130 patients were included and received either three, four or five doses of BM32 or matching placebo by s.c. injection. The study was performed in collaboration with the Vienna Challenge Chamber (VCC) group in Vienna; Dr. Petra Zieglmayer was the principle investigator. 124 patients were included in the primary analysis.
Rainer Henning, CEO of Biomay commented: "This study completes our successful phase II program for BM32. We were able to demonstrate that BM32 is able to significantly improve the incapacitating symptoms of grass pollen allergy already in the first season after start of treatment, which is obviously very important for adherence to the therapy. We very happy that this study fulfilled all our objectives. We will now work to expeditiously move BM32 into phase III trials. According to our current plans, it will be available on the market in 2021."
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.