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Cytokinetics presents results from Cohort 4 of REDWOOD-HCM
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Cytokinetics presents results from Cohort 4 of REDWOOD-HCM

Cytokinetics announced that positive results from Cohort 4 of REDWOOD-HCM, a Phase 2 clinical trial of aficamten in patients with non-obstructive hypertrophic cardiomyopathy, were presented at the American College of Cardiology 72nd Annual Scientific Session. Additionally, 48-week data from FOREST-HCM (Follow-up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM) were also presented at the meeting. Cohort 4 enrolled 41 patients with nHCM, who were New York Heart Association Class II/III with left ventricular ejection fraction greater than or equal to60% without a resting or provoked left ventricle outflow tract gradient. Eligible patients had a NT-proBNP greater than or equal to 300 pg/mL and no history of LVEF less than 45%. All patients received up to three escalating doses of aficamten, beginning with 5 mg once daily and increasing to 10 and 15 mg once daily guided by echocardiographic assessment of LVEF. Overall treatment duration was 10 weeks with a 2-week washout period. At 10 weeks, patients in Cohort 4 experienced significant improvements in NT-proBNP, with an average decrease of 66%. High-sensitivity troponin I levels also improved significantly proportional to baseline at each study visit (pless than0.05). An improvement of greater than or equal to1 NYHA Functional Class was observed in 22 of 41 patients. After the 2-week washout period, NT-proBNP and high-sensitivity troponin I levels returned to baseline levels. Aficamten was generally well-tolerated. By Week 6, 35 of patients achieved the highest dose of 15 mg of aficamten, and 6 achieved 10 mg. There were no drug discontinuations due to adverse events. One dose reduction to 10 mg occurred due to fatigue, and one temporary dose interruption occurred due to palpitation. Three patients had serious adverse events, but none were attributed to aficamten. In 27 patients, at least one treatment emergent adverse event was reported. Three patients had LVEF less than50% at Week 10; all three patients returned to baseline LVEF after the 2-week washout period. No adverse events of heart failure were reported. Meanwhile, previously presented data from FOREST-HCM showed that treatment with aficamten was associated with significant and sustained reductions in LVOT-G, improvements in New York Heart Association Functional Class, improvements in cardiac biomarkers, and improvement in self-reported health status using the Kansas City Cardiomyopathy Questionnaire through 24 weeks. New data through 48 weeks of treatment showed that aficamten was associated with significant reductions in the average resting LVOT-G. Treatment with aficamten also resulted in significant improvements in NYHA class, with 88% of patients experiencing a greater than or equal to 1 NYHA Functional Class improvement, and significant improvements in NT-proBNP, with an average decrease of 70% from baseline to Week 48. At baseline, 19 patients met eligibility criteria for septal reduction therapy, defined as NYHA Class III and peak LVOT-G greater than or equal to50 mmHg, but treatment with aficamten eliminated SRT eligibility in all 19 patients at 48 weeks. Aficamten was safe and well-tolerated, with no treatment-related serious adverse events. There were no instances of LVEF less than50% attributed to aficamten. One dose reduction and one temporary dose interruption occurred, neither of which were attributed to treatment with aficamten.

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