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Cytokinetics Announces Start of SEQUOIA-HCM, a Phase 3 Clinical Trial of Aficamten in Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Pivotal Trial to Assess the Potential of Aficamten to Improve Exercise Capacity, Heart Failure Symptoms and Functional Class SOUTH SAN FRANCISCO, Calif., Feb.
About this update from Cytokinetics, Incorporated
[{"type":"text","content":"Pivotal Trial to Assess the Potential of Aficamten to Improve Exercise Capacity, Heart Failure Symptoms and Functional Class\nSOUTH SAN FRANCISCO, Calif., Feb. 23, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), a Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM), is open to enrollment. Aficamten is a next-generation cardiac myosin inhibitor in development for the potential treatment of HCM. SEQUOIA-HCM builds on the positive results from REDWOOD-HCM, a Phase 2 clinical trial of aficamten, that demonstrated that treatment with aficamten for 10 weeks resulted in reductions from baseline compared to placebo in the average resting left ventricular outflow tract pressure gradient (LVOT-G) and the average post-Valsalva LVOT-G, with no treatment interruptions or discontinuations, nor any treatment related serious adverse events. “We are pleased to announce the start of SEQUOIA-HCM, especially today which marks HCM Awareness Day,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “With this registrational trial we are investigating the potential of aficamten to improve exercise capacity measured by peak VO2, as well as heart failure symptoms and functional class in patients who have substantial resting and provoked gradients despite standard of care therapy. Like in REDWOOD-HCM, we will use a personalized dosing scheme employing echo-guided dose titration to maximize the potential treatment effect and enable patients to reach a target dose quickly. For patients who complete SEQUOIA-HCM, we are also pleased to offer enrollment in the open label extension trial to provide patients with continued access to aficamten, and to gather longer term data on its safety and efficacy.” SEQUOIA-HCM: Clinical Trial Design SEQUOIA-HCM is a Phase 3 randomized, placebo-controlled, double-blind, international multi-center clinical trial designed to evaluate aficamten in patients with symptomatic obstructive HCM on background medical therapy for 24 weeks. The primary endpoint is the change in peak oxygen uptake (pVO2) measured by cardiopulmonary exercise testing (CPET) from baseline to Week 24. Secondary...