Biomay announced that an interim analysis for futility has been successfully completed for an ongoing phase IIb study (clinicaltrials.gov identifier NCT01538979) with its 3rd generation grass pollen allergy vaccine BM32. The study has enrolled 180 patients and is designed to show a treatment effect over two consecutive pollen seasons. An independent data management committee (DMC) has been appointed to analyse the data from the first treatment year with respect to the primary endpoint combined symptom and medication score (SMS) as well as the safety aspects of the treatment. The DMC has recommended continuation of the study into the next treatment year. All patients on active treatment will receive the lower of the two initial doses.
Rainer Henning, Chief Executive Officer, Biomay, commented, “We are satisfied with the result of this interim analysis of our most advanced product BM32. Reaching this milestone is an important step in the validation of our peptide carrier fusion protein vaccine platform. We are now looking forward with great confidence to the final read-out of the study in the fourth quarter of 2014.”
Biomay will welcome a partner for phase III development, registration and marketing of BM32 as well as for the peptide carrier fusion protein platform. 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 carrier peptide fusion proteins are constructed from the immunogenic viral coat protein PreS from 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 requires only three to four annual injections and promises to have very limited side effects. The ongoing phase IIb trial is conducted in 11 leading allergy clinics in 6 European countries and has enrolled 180 patients. The study is coordinated by Prof Johannes Ring (Klinik am Biederstein, Technical University Munich, Germany).
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.
EP News Bureau – Mumbai