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SOUTH SAN FRANCISCO, Calif., April 02, 2022 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (NASDAQ:CYTK) today announced that the full results from Cohort 3 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), the Phase 2 clinical trial of aficamten in patients with obstructive hypertrophic cardiomyopathy (HCM), were presented in a Moderated Poster Session by Anjali T. Owens, MD, Medical Director, Center for Inherited Cardiac Disease, Assistant Professor of Medicine, University of Pennsylvania, at the American College of Cardiology 71st Annual Scientific Session (ACC.22).
Cohort 3 of REDWOOD-HCM enrolled thirteen patients with symptomatic obstructive HCM and a resting or post-Valsalva left ventricular outflow tract gradient (LVOT-G) of ≥50 mmHg whose background therapy included disopyramide and, in the majority (11 out of 13 patients), a beta-adrenergic blocker. These patients remained symptomatic despite use of disopyramide and represent a group of patients resistant to available medical therapies. All patients received up to three escalating doses of aficamten once daily (5, 10, 15 mg), titrated based on echocardiographic guidance. The doses of aficamten employed were the same as those used in Cohort 1 of REDWOOD-HCM. Overall treatment duration was 10 weeks with a 4-week follow up period after the last dose. All patients completed the study on treatment.
Patients in Cohort 3 demonstrated a substantial reduction in the mean (± SD) resting LVOT-G (from 50 ± 25 at baseline to 24 ± 17 mmHg at Week 10) and Valsalva LVOT-G (from 78 ± 27 to 50 ± 25 mmHg ) (Figure 1). For the resting LVOT-G, the least square mean difference (± SE) for the change from baseline to Week 10 was -28 ± 3.2 mmHg (p < 0.0001) and for the Valsalva LVOT-G was - 27 ± 5.9 mmHg (p = 0.0002). The relief of obstruction was accompanied by a modest reduction in left ventricular ejection fraction (LVEF) (from 74 ± 7% at baseline to 69 ± 7% at Week 10) (Figure 2). For LVEF, the least square mean difference (± SE) for the change from baseline to Week 10 was -4.8 ± 1.9% (p = 0.018). There were no patients who experienced a reduction in LVEF below the prespecified safety threshold of 50% .
Treatment with aficamten resulted in 6 of the 13 patients (46%) experiencing a complete hemodynamic response by Week 10 (Figure 3), with the remaining 7 (54%) still eligible for dose escalation to the highest dose of aficamten (20 mg) employed in SEQUOIA-HCM, the Phase 3 trial. Eleven of 13 patients (85%) experienced improvement in NYHA class by at least one class (Figure 4). In addition to hemodynamic and functional capacity improvements, patients also experienced a significant improvement in NT-proBNP and trended to lower hs-troponin I (Figures 5-6). The safety and tolerability of aficamten were consistent with prior experience in REDWOOD-HCM with no dose interruptions or treatment discontinuations and no serious adverse …
Full story available on Benzinga.com
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