Biogen Idec Reports Top-Line Results from Phase 3 Trial of Dexpramipexole in People with ALS Did Not Meet Primary Endpoint
Today Biogen Idec (NASDAQ: BIIB) reported top-line results of EMPOWER, a
Phase 3 trial investigating dexpramipexole in people with amyotrophic
lateral sclerosis (ALS). The trial did not meet its primary endpoint, a
joint rank analysis of function and survival, and no efficacy was seen
in the individual components of function or survival. The trial also
failed to show efficacy in its key secondary endpoints. Additional
analyses of multiple subpopulations failed to demonstrate any efficacy
among these groups. Based on these results, Biogen Idec will discontinue
development of dexpramipexole in ALS.
"We share the disappointment of members of the ALS community, who had
hoped that dexpramipexole would offer a meaningful new treatment
option,” said Douglas E.