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Cytokinetics Announces Start of COURAGE-ALS, a Phase 3 Clinical Trial of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis
Pivotal Trial Builds on Results from FORTITUDE-ALS which Demonstrated Slowing of Declineof SVC and ALSFRS-R in Patients on Reldesemtiv Compared to Placebo
About this update from Cytokinetics, Incorporated
[{"type":"text","content":"Pivotal Trial Builds on Results from FORTITUDE-ALS which Demonstrated Slowing of Declineof SVC and ALSFRS-R in Patients on Reldesemtiv Compared to Placebo Company Is Planning to Provide Continued Access to Patients Who Complete COURAGE-ALS and Patients Who Previously Participated in Cytokinetics Sponsored ALS Trials SOUTH SAN FRANCISCO, Calif., Aug. 02, 2021 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS), a Phase 3 clinical trial of reldesemtiv in patients with amyotrophic lateral sclerosis (ALS), is open to enrollment. Reldesemtiv, a next-generation fast skeletal muscle troponin activator (FSTA) arising from Cytokinetics’ skeletal muscle contractility program, slows the rate of calcium release from the regulatory troponin complex of fast skeletal muscle fibers, which sensitizes the sarcomere to calcium, leading to an increase in skeletal muscle contractility. COURAGE-ALS follows FORTITUDE-ALS, a Phase 2 clinical trial of reldesemtiv that demonstrated encouraging results supportive of progression to a pivotal Phase 3 clinical trial. “We recognize the profound urgency to deliver new treatments to people with ALS and are pleased to open COURAGE-ALS after gathering important input from patients, regulators, advocates and the clinical community,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “As pioneers in muscle biology, we have been pursuing fast skeletal muscle activation for the potential treatment of ALS for over a decade and, based on the results from FORTITUDE-ALS, we believe there is a compelling rationale to advance reldesemtiv into this pivotal Phase 3 clinical trial, as it potentially may add to current standard of care and improve patients’ functional status and overall quality of life. We are also working toward our goal to provide continued access to reldesemtiv for participants who complete dosing in COURAGE-ALS, as well as to make it available to participants from our previously completed ALS trials.” COURAGE-ALS: Clinical Trial Design Focused on Innovation and Accessibility COURAGE-ALS, a Phase 3, multi-center, double-blind, randomized, placebo-controlled trial of reldesemtiv is expected to enroll approximately 555 patients with ALS. Pat...