BioMS Phase III study of dirucotide in MS
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Patient recruitment is complete for BioMS Medical Corp.'s Phase III trial of MBP8298 (dirucotide) for the treatment of secondary progressive multiple sclerosis. The 510-patient trial, MAESTRO-03, will be conducted in the U.S., with time to progression as the primary endpoint. Dirucotide is being developed with Lilly in three late-stage clinical trials: MAESTRO-01, a pivotal Phase II/III trials for SMPS in Canada and Europe; MAESTRO-03; and MINDSET-01, a Phase II trial for relapsing-remitting MS in Europe. In August, MAESTRO-01 got a positive nod from an independent data safety monitoring board based on an interim review of safety and efficacy data from the first 200 patients to complete the study. The drug could become a tailored therapy targeting patients with HLA-DR2 and/or HLA-DR4 immune response genes, and final data from MAESTRO-01 is anticipated in the second half of 2009