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Monday, 10/10/2022 12:58:54 PM

Monday, October 10, 2022 12:58:54 PM

Post# of 1569
Continuation of COURAGE-ALS Following First Interim Analysis

October 10 2022 - 07:30AM
GlobeNewswire Inc.

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.

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