Biomay announced today 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 analyze 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.Â
All patients on active treatment will receive the lower of the two initial doses.
Rainer Henning, CEO of Biomay, commented: â??We are extremely 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 2014â??.Â
Biomay will welcome a partner for phase III development, registration and marketing of BM32 as well as for the peptide carrier fusion protein platform.