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Cytokinetics Presents Baseline Characteristics From SEQUOIA-HCM at the HCM Society Scientific Sessions
Topline Results from SEQUOIA-HCM Expected by End of Year SOUTH SAN FRANCISCO, Calif., Oct. 06, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq:
About this update from Cytokinetics, Incorporated
[{"type":"text","content":"Topline Results from SEQUOIA-HCM Expected by End of Year\nSOUTH SAN FRANCISCO, Calif., Oct. 06, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the baseline characteristics of patients randomized in SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM), were presented at the HCM Society Scientific Sessions in Cleveland, Ohio by Martin S. Maron, M.D., Director of the Hypertrophic Cardiomyopathy Center at Lahey Hospital and Medical Center. “The baseline characteristics of SEQUOIA-HCM show that the patients enrolled into this pivotal trial align with our objectives for aficamten, which include assessing our next-in-class cardiac myosin inhibitor in a population with substantial deficit in exercise capacity and significant symptom burden despite background treatment with guideline directed medical therapies,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “We look forward to announcing topline results from SEQUOIA-HCM by the end of the year and our hopefully elaborating on clinical effects to the benefit of patients.” SEQUOIA-HCM: Baseline Characteristics SEQUOIA-HCM was designed to evaluate aficamten in patients with symptomatic obstructive HCM on background medical therapy over a 24-week period. Patients enrolled in SEQUOIA-HCM were required to have severe left ventricular outflow tract (LVOT) obstruction as evidenced by a resting LVOT-G ≥30 mmHg, a post-Valsalva peak LVOT-G ≥50 mmHg, NYHA functional class II or III, and a peak VO2 ≤90% predicted. SEQUOIA-HCM enrolled a total of 282 patients, with one third from the United States, one half from Europe and Israel, and the remainder from China. Patients were on average 59.1 years of age, 40.4% female, and 21% were non-white. Background medical therapy consisted of beta-blockers (61%), calcium channel blockers (26.6%), and disopyramide (12.8%); combination background therapy was permitted. At baseline, 75.9% of patients were NYHA functional class II, 23.8% were functional class III, and 0.4% were functional class IV. One quarter of patients were guideline-eligible for septal reduction therapy at the time of enrollment. Th...