Dirucotide Fails To Meet Primary Endpoint In Phase III MAESTRO-01 Trial

Eli Lilly and BioMS have reported that dirucotide did not meet the primary endpoint of delaying disease progression, as measured by the Expanded Disability Status Scale (EDSS). The results were obtained during the two-year MAESTRO-01 phase III trial in patients with secondary progressive multiple sclerosis (SPMS).

In addition, there were no statistically significant differences between dirucotide and placebo on the secondary endpoints of the study.

Reportedly, the data also showed that dirucotide was generally well tolerated. There were no unexpected safety or tolerability issues.

Moreover, both the companies have decided that they would discontinue ongoing clinical trials – including MAESTRO-02 and MAESTRO-03 – and review the available data from these studies.

Kevin Giese, president and CEO of BioMS, said: We are obviously disappointed by this result and will be working closely with our clinical team to evaluate these data and the available data from MAESTRO-02 and MAESTRO-03 to determine our next steps. We are fortunate to have suitable resources in place to remain flexible to pursue whatever options emerge once we understand these results more fully.