Cytokinetics has said it will be discontinuing its amyotrophic lateral sclerosis (ALS) drug candidate, reldesemtiv, following disappointing phase 3 trial results.
Data from COURAGE-ALS showed no benefit in patients treated with the fast skeletal muscle troponin activator over placebo on the primary endpoint of change from baseline to 24 weeks in ALS Functional Rating Scale-Revised (ALSFRS-R) or in key secondary endpoints.
The trial will be now concluded, the company said, along with the COURAGE-ALS-OLE open-label extension study.
Cytokinetics’ chief executive officer and president, Robert Blum, said: “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.”
ALS is a progressive nervous system disease that affects nerve cells in the brain and spinal cord, causing loss of muscle control. Approximately 27,000 people are affected by the disease in the US, where around 6,300 new cases are diagnosed each year.
Few treatment options exist for these patients, Cytokinetics said, resulting in a high unmet need for new therapies to address functional deficits and disease progression.
“Cytokinetics has been committed to the ALS community for more than a decade and recognises 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 programmes,” Blum said.
The announcement comes just a month after the US Food and Drug Administration declined to approve Cytokinetics’ heart failure drug omecamtiv mecarbil, with the regulator requesting results from an additional clinical trial.
The company said it had no plans to conduct an additional clinical trial of the drug and instead remains focused on aficamten, a cardiac myosin inhibitor currently in phase 3 development for patients with obstructive hypertrophic cardiomyopathy.
“We are disappointed with this outcome, especially considering the high unmet need for innovative treatments for patients suffering from worsening heart failure,” Blum said at the time of the announcement.
“In parallel, we look forward to continuing a broad development programme for aficamten, with expected results from SEQUOIA-HCM and the start of two more phase 3 clinical trials later this year,” he added.