Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that new
findings from analyses of claims data and electronic health records
related to heart failure and hypertrophic cardiomyopathy (HCM) were
shared in three poster presentations at the American Heart
Association (AHA) Scientific Sessions 2020. Two posters related to
heart failure included one detailing analyses of outcomes
highlighting the high unmet need in these patients with reduced
ejection fraction (HFrEF) and a worsening heart failure event, and
another one presenting data on spending for hospitalized Medicare
patients with heart failure underscoring the high costs of their
healthcare. An additional poster presented demographics and
clinical characteristics of patients with HCM.
“These presentations and analyses related to
heart failure underscore the growing economic burden of this
disease which, despite standard of care, is accompanied by a high
risk of hospitalization and cardiovascular death,” said Robert I.
Blum, President and Chief Executive Officer of Cytokinetics.
“Furthermore, the analyses of patients with HCM adds to our
understanding of this complex disease as we continue to advance and
refine our clinical development program for CK-274, our
next-in-class cardiac myosin inhibitor.”
Findings in Heart
Failure Detail High Risk Population and
High Spending Among Hospitalized
Patients
The first analysis, conducted in collaboration
with Duke Clinical Research Institute, characterized outcomes of
patients with HFrEF and a recent worsening heart failure event
(WHF), defined as an emergency department visit or hospitalization
with heart failure as the primary discharge diagnosis within 12
months prior to their index echocardiogram. A total of 3,867
patients aged 18-85 with chronic symptomatic HFrEF were identified
via electronic health records from the Duke University Health
System between January 2008 to December 2018. 1,668 (43.1%) had a
WHF event in the year prior to index echocardiogram. Patients with
a recent WHF event had more comorbidities, including the presence
of renal disease (40.5% vs. 26.7%; p<0.001) as well as higher
rates of mortality (hazard ratio 1.59; p<0.001), all-cause
hospitalization (hazard ratio 1.51; p<0.001), and heart failure
hospitalization (hazard ratio 1.85; p<0.001). Patients with a
recent WHF event also had lower ejection fraction (EF) (63.5% with
EF <25% vs. 48.4%; p<0.001) and higher NT-proBNP (3864 vs.
2443; p<0.001). Use of heart failure medication was
statistically significantly higher in those with a recent WHF event
(% on ACE-I, ARB, ARNI/Beta-Blocker/Mineralocorticoid antagonist
was 87/76/53 for the WHF group and 78/71/35 for non-WHF). These
results suggest that despite broad use of heart failure medication
in patients who experienced a worsening heart failure event, a
significant unmet need remains for new therapies.
The second analysis, conducted in collaboration
with Yale University School of Medicine, examined payments spanning
the index hospitalization through 30-days post-discharge for
Medicare beneficiaries with heart failure (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 (CKD) (I13). Of
the 935,962 patients hospitalized with HF included in the analysis,
365,274 (39.0%) were hospitalized with HHD with HF and CKD, 226,929
(24.2%) with HHD with HF, 165,156 (17.6%) with diastolic HF, and
178,603 (19.1%) with systolic HF. Over time, there was a
substantial increase in hospital admissions with a primary
diagnosis of HHD with HF with or without CKD. Payments varied
across HF diagnosis, with the highest payments for patients with
HHD with HF and CKD. 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.
These results underscore the high cost of heart failure related
health care, especially for hospitalizations.
Demographics and Clinical
Characteristics of Patients with
Obstructive HCM
In a retrospective analysis of demographics and
clinical characteristics of adult patients with obstructive HCM
(oHCM), patients were identified from electronic health records
from 39 Integrated Delivery Networks (IDN) in the IBM Explorys
database from 2010 through 2018. Of 8,792 patients, 53.0% were
female, and 81.2% Caucasian (mean index age: 61.8 years). Primary
insurance type was private (58.9%) and 54.9% of patients lived in
the Midwest. Mean BMI at index was 30.4 and 30.9% were nondrinkers.
The mean Quan-Charlson Comorbidity Index was 6.35% with the most
common comorbidities being congestive heart failure (31.9%),
chronic pulmonary disease (20.1%), and diabetes without chronic
complications (16.9%). Cardiovascular (CV) drug rates included beta
blockers (80.5%), calcium channel blockers (46.0%), ACE inhibitors
(27.7%), ARBs (18.8%), disopyramide (2.4%) and amiodarone (13.0%).
Surgical procedure rates included septal myectomy (22%), ablation
(19.8%), implantable cardioverter defibrillator (11.2%), and heart
transplantation (0.3%). Major residual side effects subsequent to
surgical procedures included atrial fibrillation (31.4%) and
reintervention (15.6%). Common reintervention procedures included
ablation and septal myectomy. The results from this analysis of a
large, diverse, national sample of patients with obstructive HCM
may be used to compare the characteristics of patients with
obstructive HCM in the general population and those treated in
centers of excellence.
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 collaborating with Amgen Inc.
(Amgen) to develop omecamtiv mecarbil, a novel cardiac muscle
activator. Omecamtiv mecarbil is the subject of an international
clinical trials program in patients with heart failure including
GALACTIC-HF, of which topline results were recently reported, and
METEORIC-HF, which is ongoing. Amgen holds an exclusive worldwide
license to develop and commercialize omecamtiv mecarbil with a
sublicense held by Servier for commercialization in Europe and
certain other countries. Cytokinetics is developing reldesemtiv, a
fast skeletal muscle troponin activator (FSTA) for the potential
treatment of ALS and other neuromuscular indications following
conduct of FORTITUDE-ALS and other Phase 2 clinical trials. The
company is considering potential advancement of reldesemtiv to
Phase 3 pending ongoing regulatory interactions. Cytokinetics is
collaborating with Astellas Pharma Inc. (Astellas) to research,
develop and commercialize other novel mechanism skeletal sarcomere
activators (not including FSTAs). Licenses held by Amgen and
Astellas are subject to specified co-development and
co-commercialization rights of Cytokinetics. Cytokinetics is also
developing CK-274, a novel cardiac myosin inhibitor that company
scientists discovered independent of its collaborations, for the
potential treatment of hypertrophic cardiomyopathies. Cytokinetics
has granted Ji Xing Pharmaceuticals Limited an exclusive license to
develop and commercialize CK-274 in China and Taiwan, in accordance
with Cytokinetics’ planned global registration programs.
Cytokinetics is conducting REDWOOD-HCM, a Phase 2 clinical trial of
CK-274 in patients with obstructive HCM. 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.
For additional information
about Cytokinetics, visit www.cytokinetics.com and follow
us on Twitter, LinkedIn, Facebook and YouTube.
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, statements relating to the GALACTIC-HF clinical trial,
including the results thereof; statements relating to the
METEORIC-HF clinical trial; 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' and
its partners' 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' or
its partners' 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;
competitive products or alternative therapies may be developed by
others for the treatment of
indications Cytokinetics' drug candidates and potential
drug candidates may target; and risks and uncertainties relating to
the timing and receipt of payments from its partners, including
milestones and royalties on future potential product sales
under Cytokinetics' collaboration agreements with such
partners. For further information regarding these and other risks
related to Cytokinetics' business, investors should
consult Cytokinetics' filings with the Securities
and Exchange Commission.
Contact:CytokineticsDiane WeiserSenior Vice
President, Corporate Communications, Investor Relations(415)
290-7757
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