Biogen Idec to drop ALS drug after failure in Ph III trial

Shares of US biotech firm Biogen Idec (Nasdaq: BIIB) fell as much as 8% to $138.05 in pre-market trading yesterday, after the company reported top-line results of EMPOWER, a Phase III trial investigating dexpramipexole in people with amyotrophic lateral sclerosis (ALS), showing that the drug 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 stock partially recovered to close down 1.4% at $147.86.

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, also known as Lou Gehrig's disease.

"We share the disappointment of members of the ALS community, who had hoped that dexpramipexole would offer a meaningful new treatment option,” said Douglas Williams, executive vice president of R&D at Biogen Idec, adding: “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.”