A large and promising drug trial has been shut down after the results came back with negligible benefits. Biogen Idec was in stage III of the trial, and had seen “encouraging signs of efficacy” in the phase II of the trial. The drug was named dexpramipexole.
The trial was composed on 943 patients in 11 countries, all with ALS. ALS is amyotrophic lateral sclerosis and has a very high death rate. Symptoms of ALS include nerve pain, paralysis, organ failure, and difficulty breathing. They divided the group into two- one was given dexpramipexole, which is a derivative of Mirapex, a Parkinson’s disease drug. The second group was given a placebo.
The results were measured on primary endpoints and secondary endpoints. The primary endpoints included function and survival. The secondary endpoints included functional decline, survival, and respiratory decline. Unfortunately, the drug did not seem to effect either endpoints. The company said, “The placebo-controlled EMPOWER trial did not show improvement in a composite measure of survival and functional ability, nor in “key secondary endpoints.”” They continued, saying, “Based on these results, Biogen Idec will discontinue development of dexpramipexole in ALS.”
Biogen Idec’s head of neurodegeneration clinical research, Douglas Kerr, MD, PhD, commented on the cancelling of the trial. “While these results were not what we expected, we hope these data will provide a foundation for future ALS research.”
Source: Med Page Today