- Cytokinetics Incorporated CYTK announced that the COURAGE-ALS Data Monitoring Committee (DMC) was recently convened to conduct the second planned interim analysis of this Phase 3 clinical trial.
- The DMC reviewed unblinded data from COURAGE-ALS and Discontinuation recommended the clinical study for futility, as it found no evidence of an effect in treated patients relative relative to placebo in the primary endpoint of change from baseline to 24 weeks in ALSFRS-R or key secondary endpoints.
- Related: Cytokinetics Releases Aficamten Data in Patients With Thickened Heart Muscle.
- The study conducted in COURAGE-ALS is being completed. In addition, Cytokinetics plans to discontinue treatment with relative 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 study endpoints.
- This interim analysis assessed the primary and key secondary endpoints for potential futility and provided for a potential fixed increase in overall enrollment if it was deemed necessary to increase the study’s statistical power or to continue the study as planned to completion.
- Price promotion: CYTK shares are up 1.80% to $34.83 on the latest check Friday.
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