Biogen Idec has announced that its EMPOWER Phase III ALS drug trial of dexpramipexole has failed to meet its primary endpoint.
Dexpramipexole, a treatment for amyotrophic lateral sclerosis (ALS), did not meet its primary endpoint of a joint rank analysis of function and survival, and no efficacy was seen in individual components of function or survival, the drug company announced today.
The trial also failed to show efficacy in its key secondary endpoints. As such, Biogen Idec has said it will abandon development of dexpramipexole in ALS.
Biogen Idec Research and Development executive vice president Dr Douglas Williams said; "We share the disappointment of members of the ALS community, who had hoped that dexpramipexole would offer a meaningful new treatment option.
"Nevertheless, the EMPOWER trial represents a significant contribution to ALS research, and Biogen Idec is committed to advancing ALS science. We continue to work with researchers around the world to understand the causes of ALS and find potential treatments for people with ALS."
The EMPOWER trial was a randomised, double-blind placebo-controlled Phase III trial of 943 people with ALS in 81 sites, covering 11 countries. Patients were randomised on a one-to-one basis to receive either dexpramipexole or placebo.
Biogen Idec Neurodegeneration Clinical Research director Dr Douglas Kerr said; "As a physician who has treated people with ALS, I hoped with all my heart for a different outcome. While these results were not what we expected, we hope these data will provide a foundation for future ALS research."
The company intends to present detailed results at a future medical conference.
