Cytokinetics New Results Presented at International Symposium on ALS

Cytokinetics, Inc. (Nasdaq: CYTK) today announced that new results were presented at the 30^th International Symposium on ALS/MND in Perth, Australia, including additional analyses from FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS), the Phase 2 clinical trial of reldesemtiv in patients with amyotrophic lateral sclerosis (ALS). Among the post-hoc analyses presented were results of subgroup analyses describing the effect of reldesemtiv with and without use of Radicava® (edaravone) and/or Rilutek® (riluzole) and the interaction between quality of life and depression in the placebo group. In collaboration with Astellas, Cytokinetics is developing reldesemtiv, a fast skeletal muscle troponin activator (FSTA), as a potential treatment for people with SMA and certain other debilitating diseases and conditions associated with skeletal muscle weakness and/or fatigue.

Effect of Reldesemtiv: Similar Whether or Not Patients Received Edaravone and/or Riluzole

The results of FORTITUDE-ALS, presented earlier this year at the American Academy of Neurology Annual Meeting, showed that the trial did not achieve statistical significance for a pre-specified dose-response relationship in the primary endpoint of change from baseline in slow vital capacity (SVC) after 12 weeks of dosing (p=0.11). However, patients on all dose groups of reldesemtiv declined numerically less than patients on placebo for SVC and ALS Functional Rating Scale-Revised (ALSFRS-R), with larger differences emerging over time. In this post-hoc subgroup analysis of all dose groups combined and compared to placebo, reldesemtiv demonstrated a similar effect on SVC, ALSFRS-R and muscle strength by hand held dynamometry (HHD) at 12 weeks whether or not patients were being treated with edaravone and/or riluzole. The majority of patients received riluzole alone (56.5%), 4.2% were receiving edaravone alone, and 20.6% were receiving both.

For use and non-use of edaravone, the treatment difference for reldesemtiv relative to placebo for ALSFRS-R was 1.25 points (p=0.06) and 0.77 points (p=0.06), respectively. Decline in SVC was 3.07 percentage points less on reldesemtiv versus placebo in patients using edaravone (p=0.14), and 1.21 percentage points less on reldesemtiv versus placebo in patients not using edaravone (p=0.32). HHD declined 6.94 percentage points less on reldesemtiv versus placebo for patients taking edaravone (p=0.14), and 1.31 percentage points on reldesemtiv versus placebo for patients not taking it (p=0.57).

For use and non-use of riluzole, the treatment difference for reldesemtiv compared to placebo for ALSFRS-R was 0.86 (p=0.03) and 0.84 (p=0.28) points, respectively. Decline in SVC was 1.64 percentage points less on reldesemtiv versus placebo (p=0.16) and 1.81 percentage points less on reldesemtiv versus placebo (p=0.46), respectively. Decline in HHD was 2.22 (p=0.36) and 4.36 (p=0.27) less on reldesemtiv versus placebo, respectively.

“The results from these subgroup analyses add to the growing body of evidence regarding the effects of reldesemtiv in patients with ALS,” said Jeremy Shefner, M.D., Ph.D., Lead Investigator of FORTITUDE-ALS, Professor and Chair of Neurology at Barrow Neurological Institute, and Professor and Executive Chair of Neurology at the University of Arizona, Phoenix. “As the treatment landscape evolves in ALS, these data demonstrate how we may be able to further slow the decline of disease progression when adding new mechanism therapies like reldesemtiv on top of existing treatment regimens.”

https://www.biospace.com/article/releases/cytokinetics-announces-new-results-presented-at-the-international-symposium-on-als-mndsubgroup-analyses-of-fortitude-als-on-effects-of-reldesemtiv-with-and-without-concomitant-radicava-edaravone-or-rilutek-riluzole-/