Eli Lilly and partner BioMS Medical Corp‘s dirucotide has failed a late-stage trial as a potential treatment for multiple sclerosis.
The companies noted that dirucotide did not meet the primary endpoint of delaying disease progression during the two-year MAESTRO-01 Phase III trial in patients with secondary progressive multiple sclerosis. They added that there were no statistically significant differences between the drug and placebo on the secondary endpoints of the study.
Dirucotide was generally well tolerated and there were no unexpected safety or tolerability issues, though Lilly and BioMS noted that the most common side effect reported was injection site reaction. As a result of this setback, the firms are discontinuing ongoing trials, including MAESTRO-03, a 510-patient Phase III study that completed enrollment in August last year.
John Hayes, vice president of Lilly Research Laboratories, said the MAESTRO-01 study “was well designed and executed, and we believe these data, while disappointing, are very instructive for us and for the larger MS community,” Kevin Gliese, BioMS chief executive, added that “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”.
He added that BioMS is “fortunate to have suitable resources in place to remain flexible to pursue whatever options emerge once we understand these results more fully”. Investors were non-plussed however and the Canadian company’s shares sank by over 50%.
Lilly paid BioMS an upfront payment of $87 million in January 2008 for the rights to dirucotide, then known as MBP8298. The deal could have brought in milestones of up to $410 million to the Edmonton-headquartered firm, plus royalties, if the drug had proved to be a success.
