Business
Cytokinetics Announces New Results Presented at the International Symposium on ALS/MND
Subgroup Analyses of FORTITUDE-ALS on Effects of Reldesemtiv with and without Concomitant Radicava® (edaravone) or Rilutek® (riluzole) SOUTH SAN FRANCISCO,
About this update from Cytokinetics, Incorporated
[{"type":"text","content":"Subgroup Analyses of FORTITUDE-ALS on Effects of Reldesemtiv with and without Concomitant Radicava® (edaravone) or Rilutek® (riluzole)\nSOUTH SAN FRANCISCO, Calif., Dec. 05, 2019 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that new results were presented at the 30th 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.\n 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 ...