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April 29, 2014
07:41 EDTCYTKCytokinetics announces additional results from BENEFIT-ALS
Cytokinetics announced additional results from Blinded Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv in ALS, or BENEFIT-ALS. In BENEFIT-ALS, 711 patients with amyotrophic lateral sclerosis, or ALS, were enrolled into the open-label phase; subsequently 605 patients were randomized 1:1 to double-blind treatment with either tirasemtiv or placebo for 12 weeks. As previously announced, 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. Secondary endpoints evaluated measures of respiratory performance and other measures of skeletal muscle function and fatigability. Treatment with tirasemtiv resulted in a statistically significant and potentially clinically meaningful reduction in the decline of Slow Vital Capacity that has been shown to be an important predictor of disease progression and survival in prior trials of patients with ALS. This pre-specified secondary efficacy endpoint also declined less on tirasemtiv than on placebo at each assessment time point.
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