Dirucotide (MBP8298)

Parent company: BioMS

• Administered intravenously every six months.


• 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.


• Early trials showed that dirucotide was safe and tolerable, and delayed the median time to disease progression by five years in people with SPMS. MAESTRO-01 is a Phase III trial in patients with SPMS, followed up by MAESTRO-02 (an open-label study). MAESTRO-03 is a phase III trial in 510 people with SPMS.


• In late July 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 SPMS as measured by EDSS. As a result of these findings, ongoing studies will be discontinued. Lilly and BioMS will continue to evaluate available data and determine how to proceed.


• In a small RRMS trial (MINDSET-01), dirucotide did not affect the primary outcome of clinical attacks versus placebo.