Dirucotide (MBP8298) Update
On July 27, 2009, Eli Lilly and BioMS Medical Corporation announced that dirucotide did not meet the primary endpoint of the MAESTRO-01 study, which was the delay of disease progression in secondary-progressive MS (SPMS) as measured by EDSS (Expanded Disability Status Scale).
With secondary endpoints (degree of change in EDSS and MRI changes), no statistically significant differences were found between the treated and placebo groups.
As a result of these findings, ongoing studies will be discontinued, including MAESTRO-02 and MAESTRO-03. MAESTRO-01 is a Phase III trial in patients with SPMS, which was being followed up with MAESTRO-02 (an open-label study). MAESTRO-03 is a phase III trial in 510 people with SPMS who were to be followed for two years. In a small RRMS trial (MINDSET-01), dirucotide did not affect the primary outcome of clinical attacks versus placebo.
This synthetic fragment of myelin basic protein (MBP) replicates the site on the MBP molecule that is believed to be a target of attack by cells of the immune system. It appears to inhibit the immune system from damaging myelin. Early trials showed that dirucotide was safe and tolerable, and delayed the median time to disease progression by five years in people with SPMS.
Lilly and BioMS will continue to evaluate available data and determine how to proceed.
Written by Susan Wells Courtney, MSAA Senior Writer & Creative Director
Reviewed by Dr. Jack Burks, MSAA Chief Medical Officer