Cytokinetics Presents New Data From REDWOOD-HCM OLE in Late Breaking Clinical Trial Session at the HFSA Annual Scientific Meeting
Treatment with Aficamten Associated with Significant Improvements in Symptoms and Quality of Life
Additional Data Presented in Poster Session Shows Patients with Worsening Heart Failure and LVEF ≤30% Have Disproportionately High Risk of Heart Failure Hospitalization
Previously presented data from REDWOOD-HCM open label extension (OLE) showed that treatment with aficamten was associated with significant and sustained reductions in left ventricular outflow tract gradient (LVOT-G), improvements in
This new analysis evaluates patients’ self-reported health status using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and compares baseline values to those collected at Week 12 and Week 24. The KCCQ is a validated patient reported outcomes tool1 used to evaluate heart failure symptoms and their impact on social and physical limitations as well as quality of life. Higher scores indicate better health status. As early as Week 12, patients experienced substantial and significant symptom improvements as measured by the change in their KCCQ scores. The KCCQ Overall Summary Score (KCCQ-OSS) and all KCCQ sub-domain scores demonstrated these improvements, improvements which were also noted to be sustained through Week 24. At 12 and 24 weeks, the change from baseline (mean [SD]) change in KCCQ-OSS was 16.5 [16.7] (p<0.0001) and 17.6 [24.7] (p=0.0015). The proportion of patients with clinically important improvements (improvement ≥5 points on the KCCQ-OSS) was 72.7% at Week 12 and 72.0% at Week 24, and 36.4% of patients at Week 12 and 40.0% at Week 24 reported a very large clinical improvement (≥20 points). (Figure 1)
“These new data suggest that improvements in cardiac function associated with treatment with aficamten translate to patients reporting an overall improvement in their symptoms – particularly in their quality of life – which is of critical importance to patients with HCM who face a substantial symptom burden that impacts their daily lives.” said
Literature Synthesis Finds Patients with Worsening Heart Failure and LVEF ≤30% have Disproportionately High Risk of Heart Failure Hospitalization
In patients with heart failure with reduced ejection fraction (HFrEF), previous work has identified that worsening heart failure (WHF) and lower left ventricular ejection fraction (LVEF) are risk factors for cardiovascular (CV) death and HF hospitalization. However, gaps remain in understanding the relative impact of these factors. A new analysis conducted in partnership with
Aficamten is an investigational selective, small molecule cardiac myosin inhibitor discovered following an extensive chemical optimization program that was conducted with careful attention to therapeutic index and pharmacokinetic properties and as may translate into next-in-class potential in clinical development. Aficamten was designed to reduce the number of active actin-myosin cross bridges during each cardiac cycle and consequently suppress the myocardial hypercontractility that is associated with hypertrophic cardiomyopathy (HCM). In preclinical models, aficamten reduced myocardial contractility by binding directly to cardiac myosin at a distinct and selective allosteric binding site, thereby preventing myosin from entering a force producing state. The development program for aficamten is assessing its potential as a treatment that improves exercise capacity and relieves symptoms in patients with HCM as well as its long-term effects on cardiac structure and function. Aficamten received Breakthrough Therapy Designation for the treatment of symptomatic obstructive HCM from the
About Hypertrophic Cardiomyopathy
Hypertrophic cardiomyopathy (HCM) is a disease in which the heart muscle (myocardium) becomes abnormally thick (hypertrophied). The thickening of cardiac muscle leads to the inside of the left ventricle becoming smaller and stiffer, and thus the ventricle becomes less able to relax and fill with blood. This ultimately limits the heart’s pumping function, resulting in symptoms including chest pain, dizziness, shortness of breath, or fainting during physical activity. A subset of patients with HCM are at high risk of progressive disease which can lead to atrial fibrillation, stroke and death due to arrhythmias.
About Heart Failure
Heart failure is a grievous condition that affects more than 64 million people worldwide2 about half of whom have reduced left ventricular function.3,4 It is the leading cause of hospitalization and readmission in people age 65 and older.5,6 Despite broad use of standard treatments and advances in care, the prognosis for patients with heart failure is poor.7 An estimated one in five people over the age of 40 are at risk of developing heart failure, and approximately 50 percent of people diagnosed with heart failure will die within five years of initial hospitalization.8,9 More than 2 million people in the U.S. are estimated to have an ejection fraction <30%, indicating they may have severe heart failure.10
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act").
CYTOKINETICS® and the
Senior Vice President, Corporate Communications, Investor Relations
Michael Nassif, Jennifer T Fine, Chantal Dolan, Matthew Reaney, Prithvi Addepalli,, Veleka D Allen, Amy J Sehnert, Kensey Gosch, John A Spertus. Validation of the Kansas City Cardiomyopathy Questionnaire in Symptomatic Obstructive Hypertrophic Cardiomyopathy. JACC Heart Fail. 2022 Aug;10(8):531-539.
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Source: Cytokinetics, Incorporated