Cytokinetics to Continue ALS Trial Following First Interim Analysis

 Phase 3 Clinical Trial to Proceed to Second Interim Analysis Expected to Occur in 2023

Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the Data Monitoring Committee (DMC) for COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS), recently convened to conduct the first planned interim analysis of this ongoing Phase 3 clinical trial which assessed for the potential of futility. The DMC reviewed unblinded data from COURAGE-ALS and recommended that conduct of the clinical trial of reldesemtiv continue. Reldesemtiv is a fast skeletal muscle troponin activator (FSTA) in clinical development for the potential treatment of amyotrophic lateral sclerosis (ALS).

The first interim analysis was triggered 12 weeks after approximately one-third or more of the intended number of patients were randomized to participate in COURAGE-ALS. A second interim analysis, which is anticipated to occur in the first half of next year, will also assess for potential futility and will also allow for a fixed increase in total enrollment, if deemed necessary, to augment the statistical power of the trial.

https://finance.yahoo.com/news/cytokinetics-announces-continuation-courage-als-113000012.html