Cytokinetics halts Phase III reldesemtiv trial due to futility

1 April 2023
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US muscle biology specialist Cytokinetics’ (Nasdaq: CYTK) shares closed up 2.9% at $35.19 on Friday, despite reporting that the Data Monitoring Committee (DMC) for the Phase III COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS) has recommended discontinuation of the clinical trial due to futility as a treatment for amyotrophic lateral sclerosis (ALS).

The study 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.

Given these results, study conduct in COURAGE-ALS will be concluding. In addition, Cytokinetics plans to discontinue treatment with reldesemtiv in all patients including those in the open-label extension study, COURAGE-ALS OLE.

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