COURAGE-ALS Phase 3 clinical trial second interim analysis did not meet endpoints

March 31, 2023 – Cytokinetics has announced that the COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS) Phase 3 clinical trial will be discontinued. A second interim analysis of Phase 3 COURAGE-ALS data met criteria for futility, meaning there was no evidence of an effect in people treated with reldesemtiv relative to those treated with placebo on the primary or key secondary endpoints.  

As a result, the study will conclude and all participants, including those in the open-label extension study COURAGE-ALS OLE, will no longer receive treatment with reldesemtiv. We know this therapy is of interest to the ALS community and share Cytokinetic’s disappointment in the results. 

“We are extremely disappointed with this outcome and would like to thank the people with ALS, caregivers, investigators and clinical trial staff for their participation in COURAGE-ALS,” said Robert I. Blum, Cytokinetics’ CEO and President. “Cytokinetics has been committed to the ALS community for more than a decade and recognizes the urgency to bring new potential medicines to the forefront for this grievous disease. In the coming months, we will assess next steps relating to our neuromuscular development programs.”

You can read more about the COURAGE-ALS Phase 3 trial and the results here.