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Cytokinetics Presents Results From COURAGE-ALS at the 34th International Symposium on ALS/MND
As Previously Announced, Reldesemtiv Had No Effect on the Primary Endpoint of Change from Baseline in ALSFRS-R or Key Secondary Endpoints Trial Discontinued
About this update from Cytokinetics, Incorporated
[{"type":"text","content":"As Previously Announced, Reldesemtiv Had No Effect on the Primary Endpoint of Change from Baseline in ALSFRS-R or Key Secondary Endpoints Trial Discontinued in March 2023 Due to Futility Following Second Planned Interim Analysis Survey Reveals Site Personnel and Patients Have Favorable View of Trial Features to Reduce Burden of Participation SOUTH SAN FRANCISCO, Calif., Dec. 07, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the full results of COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS), were presented at the 34th International Symposium on ALS/MND by Jeremy Shefner, M.D., Ph.D., Lead Investigator of COURAGE-ALS, Professor of Neurology, Barrow Neurological Institute, University of Arizona College of Medicine Phoenix. COURAGE-ALS was designed with two planned interim analyses of unblinded data by the Data Monitoring Committee. At the second interim analysis the Data Monitoring Committee recommended the discontinuation of the clinical trial due to futility. Subsequently, the Company concluded study conduct in March 2023 and discontinued treatment with reldesemtiv in all patients including those in the open-label extension study, COURAGE-ALS OLE. Development of reldesemtiv has been terminated. At the time of the discontinuation of COURAGE-ALS, 486 patients had started treatment with reldesemtiv or placebo and 276 had completed dosing through 24 weeks. Treatment with reldesemtiv for 24 weeks had no effect on the primary efficacy endpoint measure of change from baseline up to Week 24 in the ALS Functional Rating Scale Revised (ALSFRS-R) (joint rank test p=0.11). Patients treated with reldesemtiv declined 5.3 points per month (SD=5.3) while patients treated with placebo declined 4.8 points per month (SD=4.4). No pre-defined patient subgroup favored treatment with reldesemtiv. Patients with a faster disease progression rate did not experience a greater treatment effect from reldesemtiv, contrary to analyses conducted post hoc from FORTITUDE-ALS, the Phase 2 clinical trial of reldesemtiv, which had suggested that treatment effects were more evident in patients with a faster disease progression rate. Reldesemtiv also demonstrated no effect on key secondary endpoints including change from baseline to Week 24 in in-clinic percent predicted forced vita...