Cytokinetics Plans To Discontinue Late-Stage ALS Trial Due To Futility

Cytokinetics Incorporated CYTK announced that the Data Monitoring Committee (DMC) for COURAGE-ALS recently convened to conduct the second planned interim analysis of this Phase 3 clinical trial.
The DMC reviewed unblinded data from COURAGE-ALS and recommended discontinuing the clinical trial due to futility, as it found no evidence of effect in patients treated with reldesemtiv relative to placebo on the primary endpoint of change from baseline to 24 weeks in ALSFRS-R or in key secondary endpoints.
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The study conducted in COURAGE-ALS will be concluded. In addition, Cytokinetics plans to discontinue treatment with reldesemtiv in all patients, including those in the open-label extension study, COURAGE-ALS OLE.
The second interim analysis was triggered 24 weeks after at least one-third of the planned sample size was randomized in COURAGE-ALS.
At the interim analysis, approximately 460 patients had been randomized and over 200 had reached the 24-week assessment of the trial endpoints.
This interim analysis assessed the primary and key secondary endpoints for potential futility and provided for a potential fixed increase in total enrollment if it had been deemed necessary to augment the trial's statistical power or to continue the trial to its conclusion as planned.
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