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.