The company Cytokinetics has announced early termination of the COURAGE-ALS study. An interim analysis of the results found no evidence of the drug’s effectiveness. No difference in disease progression was observed between participants who received the study drug and participants who received the placebo (fake drug).
In this phase 3 study, the drug ‘Reldesemtiv’ was investigated. A phase 3 study is a large-scale study investigating the safety and efficacy of a drug. More than 400 people with ALS worldwide participated in the study.
Reldesemtiv was expected to have a beneficial effect on muscle function. Unfortunately, the interim analysis showed that the drug did not deliver the expected result and this result will also not occur if the study continues. The assessment committee therefore decided to discontinue the study. No adverse effects of the study drug were observed.
The termination of this study does not affect other ongoing drug trials.
Comment by TRICALS
“We had great hope that this drug would be effective in slowing down the disease. It is therefore very disappointing that we have to discontinue the study early. This is a huge setback for everyone who participated in the study and for all people with ALS. The need for effective drugs is high. However, our motivation to find a treatment for ALS remains undiminished. With global collaboration and many studies currently underway, we are hopeful that there will be light at the end of the tunnel. We would like to thank everyone who participated in the study for their efforts. Despite the negative outcome, the results provide insights that can be used for future research.” – Leonard van den Berg – Neurologist and chair of TRICALS
Participation in drug research
To find a treatment for ALS, it is important that people continue to participate in research. Would you like to participate in drug research and be informed when new studies start? Register yourself with TRICALS.TRICALS Registry