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UPDATE: Cytokinetics Reports Top-Line Results from BENEFIT-ALS Showed Did Not Reach Primary Efficacy Endpoint, Mixed Effects on Secondary Endpoints

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Cytokinetics, Incorporated (Nasdaq: 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."

Posted-In: News FDA Press Releases


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