DME recommends continuation of COURAGE-ALS trial of reldesemtiv following first interim analysis
Cytokinetics, Incorporated 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 III 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.
The development program for reldesemtiv is assessing its potential for the treatment of ALS and includes FORTITUDE-ALS, a completed Phase II trial, and COURAGE-ALS, the ongoing Phase III clinical trial designed to evaluate the effect of treatment with reldesemtiv compared to placebo on measures of disease progression, functional outcomes and survival.
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