Date: 2017-01-26
Type of
information: Completion of the trial
phase: 2
Announcement: completion of the trial
Company: Biomay (Austria)
Product: BM32
Action
mechanism:
- fusion protein/immunotherapy product. BM32 is a grass pollen allergy vaccine based on recombinant peptide carrier technology invented in the lab of Prof. Rudolf Valenta at the Medical University of Vienna. 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.
Disease: grass pollen allergy
Therapeutic
area: Allergic diseases
Country: Austria
Trial
details:
- BM32 is a product for immunotherapy of grass pollen allergies. It consists of 4 different recombinant proteins (BM321, BM322, BM325 and BM326) adsorbed on alhydrogel. This prospective, double-blind. placebo controlled, mono-centric trial investigates the levels of allergen specific IgG antibodies following 3, 4 or 5 subcutaneous injections before the grass pollen season.
- 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. (NCT02643641)
Latest
news:
- • On January 26, 2017, Biomay announced that a second phase IIb study 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?g 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. 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.
- • On January 28, 2016, Biomay announced that a new phase II trial with the grass pollen allergy vaccine BM32 based on the proprietary peptide carrier protein platform has been initiated. The aim of the study is the optimization of the dose regimen of BM32 to achieve optimal allergen specific blocking immune response in grass pollen allergy patients and thereby maximized protection from allergic symptoms during the pollen season.
- The study follows a novel design by linking a combined symptom and medication score recorded with a patient diary with measurement of grass pollen sensitivity in an environmental exposure chamber. The study protocol has been conceived together with the Vienna Challenge Chamber (VCC), which also acts as the study site. Specific IgG immune response against the four major timothy grass pollen allergens Phl p 1, Phl p 2, Phl p 5 and Phl p 6 is the primary outcome measure of the trial.
- The study has already enrolled 133 patients and will read out in the fourth quarter of 2016. The results will set BM32 up for progression into phase III registration studies.
Is
general: Yes
