Cytokinetics Announces Presentations Related to Health Economics and Outcomes Research in Heart Failure and Hypertrophic Cardiomyopathy at American College of Cardiology 70th Annual Scientific Session & Expo (ACC.21)

South San Francisco, California, UNITED STATES


SOUTH SAN FRANCISCO, Calif., May 16, 2021 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that new findings from analyses of claims data and electronic health records related to heart failure (HF) and hypertrophic cardiomyopathy (HCM) were shared in two poster presentations at the American College of Cardiology 70th Annual Scientific Session & Expo (ACC.21). One poster presented data on spending for hospitalized Medicare patients with HF underscoring the economic burden of their healthcare, and an additional poster presented demographics and clinical characteristics of patients with hypertrophic cardiomyopathy.

“Together these analyses highlight the severity, complexity and burden associated with each of heart failure and hypertrophic cardiomyopathy as well as the high costs associated with managing the cycle of hospitalization and readmission for patients with heart failure,” said Robert I. Blum, President and Chief Executive Officer of Cytokinetics. “Our collaborative research initiatives with leading teaching institutions and health economics experts continue to inform our understanding of the clinical and economic burden and underscore how potential new therapies may improve health outcomes.”

High Spending Among Medicare Patients Hospitalized with Heart Failure and Substantial Payments for Post-Acute Care

This analysis builds upon a previously presented analysis conducted in collaboration with Yale University School of Medicine examining payments spanning index hospitalization through 30-days post-discharge for Medicare beneficiaries with HF. Using Medicare fee-for-service administrative claims data, patients hospitalized with HF from 2016-2018 were identified with the following primary discharge diagnoses (ICD-10 codes): systolic HF (50.2 and 50.4), diastolic HF (50.3), hypertensive heart disease (HHD) with HF (I11), and HHD with HF and chronic kidney disease (I13). The total estimated mean Medicare 30-day payments for HF care were approximately $16.5 billion over the 3-year study period, with little change in spending year to year.

This new analysis of the same dataset examined 90-day post-discharge spending and found that the total estimated Medicare 90-day payments were approximately $27 billion over the 3-year study period. The index hospitalization accounted for 35% of the total mean 90-day payments. The remaining 65% of payments occurred in the post-acute care period (mean $11,374), driven by payments for readmission including observation stays (36% of post-acute care payments; mean $6,828) and skilled nursing facilities (27% of post-acute care payments; mean $5,192). Overall, 36% of Medicare patients hospitalized with HF were readmitted within 90 days. These results further emphasize the high cost of HF related health care, not only for initial hospitalization but for readmission and ongoing care.

Retrospective Observation of Patients with Obstructive HCM Finds Increase in Cardiovascular Comorbidities and Medication Use Over 2-Year Follow-Up

In a retrospective analysis of demographics and clinical characteristics of adult patients with obstructive HCM (oHCM), the first to examine a national sample using longitudinal medical and pharmacy claims data, patients were identified using claims data from the HealthCore Integrated Research Database (HIRD®), a database representing over 50 million people who are commercially insured or Medicare Advantage members in the United States, between January 1, 2012 to January 31, 2020. Patient characteristics and outcomes were reported for the 12-month period before the index date (the earliest diagnosis of oHCM) and a 2-year follow-up. Of the 1,841 patients identified with oHCM, 52% were male and the average age was 63.2 years. Cardiovascular comorbidities were common at the 2-year follow-up, including hypertension (64%), coronary artery disease (31%), atrial fibrillation (26%), HF (24%), and diabetes (21%). Between the 12-month baseline and 2-year follow up the percentage of patients with diagnostic procedures and myocardial imaging increased, as did the use of HCM-related medications (p < 0.01) including β-blockers (59% vs 70%), calcium channel blockers (29% vs 33%), anticoagulants (14% vs 22%), and antiarrhythmics (all: 6% vs 10%; disopyramide: 1% vs 3%). At the 2-year follow-up, 144 patients (8%) had received an implantable cardioverter-defibrillator for sudden death prevention and 123 patients (6%) underwent septal reduction procedures (5% myectomy; 1% alcohol septal ablation), with the mean time from initial evaluation to procedure being 218 days and 97 days, respectively. The results from this analysis, may help characterize the population of patients with oHCM and understand their disease progression to better support current treatment approaches and inform development of novel therapies to address this unmet need.

About Cytokinetics

Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility. Cytokinetics is engaging with regulatory authorities in preparation for a U.S. NDA submission of omecamtiv mecarbil, its novel cardiac muscle activator, following positive results from GALACTIC-HF, a large, international Phase 3 clinical trial in patients with HF. Cytokinetics is conducting METEORIC-HF, a second Phase 3 clinical trial of omecamtiv mecarbil. Cytokinetics is also developing CK-274, a next-generation cardiac myosin inhibitor, for the potential treatment of HCM. Cytokinetics is conducting REDWOOD-HCM, a Phase 2 clinical trial of CK-274 in patients with obstructive HCM. Cytokinetics is also developing reldesemtiv, a fast skeletal muscle troponin activator for the potential treatment of ALS and other neuromuscular indications following conduct of FORTITUDE-ALS and other Phase 2 clinical trials. The company is preparing for the potential advancement of reldesemtiv to a Phase 3 clinical trial in ALS. Cytokinetics continues its over 20-year history of pioneering innovation in muscle biology and related pharmacology focused to diseases of muscle dysfunction and conditions of muscle weakness.

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Forward-Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act's Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, the potential benefits of omecamtiv mecarbil, including its ability to represent a novel therapeutic strategy to increase cardiac muscle function and restore cardiac performance; the timing and likelihood of regulatory approval for omecamtiv mecarbil, Cytokinetics'  research and development activities; the design, timing, results, significance and utility of preclinical and clinical results; and the properties and potential benefits of Cytokinetics' other drug candidates. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics' drug candidates that could slow or prevent clinical development or product approval; Cytokinetics' drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics'  ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; the nature of Amgen's decisions with respect to the design, initiation, conduct, timing and continuation of development activities for omecamtiv mecarbil; standards of care may change, rendering Cytokinetics' drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics' drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission.

Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Communications, Investor Relations
(415) 290-7757