Results from the Phase 2 clinical trial of FORTITUDE-ALS have recently been made available. Here is the update from MND Australia. "The trial failed to meet either of its primary or secondary endpoints, with the trial finding the following:
- no statistical significance demonstrated for change in slow vital capacity (SVC) from baseline following 12 weeks of dosing; and
- dose-response analyses for the secondary endpoint failed to demonstrate statistical significance between reldesemtiv and the placebo arms.
However, data did reveal that all patients who received reldesemtiv declined less for both SVC and ALSFRS-R (revised Amyotrophic Lateral Sclerosis Functional Rating Scale), when compared to those taking the placebo. The full press release from the American Academy of Neurology is available here.
A spokesperson from Cytokinetics said: “While FORTITUDE-ALS did not meet the primary endpoint, we are encouraged by the results of the trial as they further validate the potential of skeletal muscle activation in treating patients battling ALS … This Phase II trial of reldesemtiv demonstrated consistency of effect for doses, endpoints, and time points and we believe the results support progression of reldesemtiv in further clinical trials toward potential registration.”
Cytokinetics have recently uploaded a webcast that discusses the results of the trial in further detail."