Successful phase IIB trial with third-generation grass pollen allergy vaccine BM32
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 80 µg of BM32 was statistically significantly superior to all other dosing schemes in terms of induction of 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 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 of highest pollen exposure (p<0.05) in this dose group. The effect size of these important clinical endpoints is highly clinical relevant. In a pollen chamber session following 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 resolved within a short period after drug application.
In this placebo-controlled, double-blind, prospective study, 128 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 patients already in the first season after start of treatment, which is obviously very important for adherence to the therapy. We are very happy that this study fulfilled all our objectives. We now will work to expeditiously to move BM32 into phase III trials. According to 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.
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.