Cytokinetics, Incorporated CYTK announced today the top-line results of BENEFIT-ALS (Blinded Evaluation
of Neuromuscular Effects and Functional Improvement with Tirasemtiv in ALS).
Detailed results will be presented during the 66^th Annual Meeting of the
American Academy of Neurology (AAN) on Tuesday, April 29th at the Pennsylvania
Convention Center in Philadelphia, PA.
BENEFIT-ALS did not achieve its primary efficacy endpoint, the mean change
from baseline in the ALS Functional Rating Scale in its revised form
(ALSFRS-R) on tirasemtiv versus placebo (-2.98 points in the tirasemtiv group
versus -2.40 points in the placebo group, p = 0.11). Secondary efficacy
analyses of the effect of tirasemtiv on respiratory function and other
measures of skeletal muscle function produced mixed results.
"Patients with ALS desperately need new therapeutic alternatives to slow the
course of their disease and loss of function. We stand with the ALS community
in our disappointment that BENEFIT-ALS did not achieve its primary efficacy
endpoint," stated Robert I. Blum, Cytokinetics' President and Chief Executive
Officer. "The results from BENEFIT-ALS are just now becoming available to our
team at Cytokinetics and will be shared in more detail with the broader
scientific and medical community focused to research in ALS in the next few
days. Understanding these results will require significant further review.
Once we have fully evaluated the data from BENEFIT-ALS, we expect to determine
whether there is a potential development path forward for tirasemtiv for the
potential treatment of ALS and what may be the appropriate next steps."
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