Cytokinetics Announces Topline Data From Phase 1 Clinical Study of CK-4021586
08 Mai 2024 - 1:30PM
Cytokinetics, Incorporated (Nasdaq: CYTK) today announced topline
data from the Phase 1 study of CK-4021586 (CK-586). The study met
its primary and secondary objectives to assess the safety,
tolerability and pharmacokinetics (PK) of single and multiple oral
doses of CK-586. The data support the advancement of CK-586 to a
Phase 2 clinical trial in patients with heart failure with
preserved ejection fraction (HFpEF) which is expected to begin in
Q4 2024. CK-586 is a cardiac myosin inhibitor in development for
the potential treatment of a subgroup of patients with HFpEF.
“These data reinforce the potential of CK-586 as
a drug candidate designed to directly impact the underlying
hypercontractility in a subset of patients with HFpEF,” said Fady
I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President,
Research and Development. “Based on previously reported positive
Phase 2 results of aficamten in patients with non-obstructive HCM,
we are confident in this approach in HFpEF as the conditions have a
similar profile. We look forward to starting the Phase 2 clinical
trial of CK-586 in the fourth quarter, further extending the
potential of our cardiac myosin directed development platform
focused to specialty cardiology indications.”
Phase 1 Design and Key
Findings
The primary objective of this Phase 1
double-blind randomized, placebo-controlled, multi-part single and
multiple ascending dose clinical study was to evaluate the safety,
tolerability and PK of CK-586 when administered orally as single or
multiple doses to healthy participants. The study design included
seven single ascending dose cohorts (10 mg to 600 mg) comprised of
10 participants each, and two multiple-dose ascending cohorts (100
and 200 mg once daily) comprised of 10 participants each. The study
met the primary objective, demonstrating that CK-586 was safe and
well tolerated in healthy participants with linear PK.
Pharmacodynamics were evaluated using echocardiography and
consistent with expectations. No serious adverse events were
observed, and the stopping criteria were not met in the study.
About CK-4021586 (CK-586)
CK-4021586 (CK-586) is a novel, selective, oral,
small molecule cardiac myosin inhibitor designed to reduce the
hypercontractility associated with heart failure with preserved
ejection fraction (HFpEF). In preclinical models, CK-586 reduced
cardiac hypercontractility by decreasing the number of active
myosin cross-bridges during cardiac contraction thereby reducing
the contractile force, without effect on calcium transients. In
some patients, HFpEF is a condition that resembles non-obstructive
hypertrophic cardiomyopathy (HCM) in that the patients have higher
ejection fractions, thickened walls of their heart, elevated
biomarkers, and symptoms of heart failure. In a Phase 2 clinical
trial in patients with non-obstructive HCM, aficamten, a cardiac
myosin inhibitor also developed by the Company, was well tolerated,
improved patient reported outcomes (Kansas City Cardiomyopathy
Questionnaire (KCCQ) and New York Heart Association (NYHA)
Functional Class) and biomarkers, measures that are also relevant
to HFpEF, lending support for this mechanism of action in
HFpEF.
About Heart Failure
Heart failure is a grievous condition that
affects more than 64 million people worldwide.1 Approximately 6.7
million Americans have heart failure, which is expected to increase
to over 8.5 million Americans by 2030.2 Approximately half of
patients with heart failure have heart failure with preserved
ejection fraction (HFpEF)3, and the prevalence of HFpEF is
increasing.2,4 Approximately 75% of patients with HFpEF will die
within five years of initial hospitalization, and 84% will be
rehospitalized.2 Despite broad use of standard treatments and
advances in care, the prognosis for patients with heart failure is
poor.5
About Cytokinetics
Cytokinetics is a late-stage, specialty
cardiovascular 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 cardiac muscle performance is
compromised. As a leader in muscle biology and the mechanics of
muscle performance, the company is developing small molecule drug
candidates specifically engineered to impact myocardial muscle
function and contractility. Cytokinetics is preparing for
regulatory submissions for aficamten, its next-in-class cardiac
myosin inhibitor, following positive results from SEQUOIA-HCM, the
pivotal Phase 3 clinical trial in obstructive hypertrophic
cardiomyopathy. Aficamten is also currently being evaluated in
MAPLE-HCM, a Phase 3 clinical trial of aficamten as monotherapy
compared to metoprolol as monotherapy in patients with obstructive
HCM, ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients
with non-obstructive HCM, CEDAR-HCM, a clinical trial of aficamten
in a pediatric population with obstructive HCM, and FOREST-HCM, an
open-label extension clinical study of aficamten in patients with
HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac
muscle activator, in patients with heart failure. Additionally,
Cytokinetics is developing CK-586, a cardiac myosin inhibitor with
a mechanism of action distinct from aficamten for the potential
treatment of HFpEF, and CK-136, a cardiac troponin activator for
the potential treatment HFrEF and other types of heart failure,
such as right ventricular failure resulting from impaired cardiac
contractility.
For additional information about Cytokinetics,
visit www.cytokinetics.com and follow us on X, 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, express or implied, relating to the
potential benefits of CK-586 for patients with heart failure with
preserved ejection fraction (HFpEF) and our ability to commence a
Phase 2 clinical trial of CK-586 in the fourth quarter of 2024, if
ever. 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; 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.
CYTOKINETICS® and the C-shaped logo are
registered trademarks of Cytokinetics in the U.S. and certain other
countries.
Contact:Cytokinetics Diane WeiserSenior Vice
President, Corporate Affairs(415) 290-7757
References:
- James et al. GBD 2017 Disease and Injury Incidence and
Prevalence Collaborators. Lancet 2018; 392:
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- Bozkurt B, Ahmad T, Alexander KM, Baker WL, Bosak K, Breathett
K, Fonarow GC, Heidenreich P, Ho JE, Hsich E, Ibrahim NE, Jones LM,
Khan SS, Khazanie P, Koelling T, Krumholz HM, Khush KK, Lee C,
Morris AA, Page RL 2nd, Pandey A, Piano MR, Stehlik J, Stevenson
LW, Teerlink JR, Vaduganathan M, Ziaeian B; Writing Committee
Members. Heart Failure Epidemiology and Outcomes Statistics: A
Report of the Heart Failure Society of America. J Card Fail. 2023
Oct;29(10):1412-1451. doi: 10.1016/j.cardfail.2023.07.006. Epub
2023 Sep 26. PMID: 37797885; PMCID: PMC10864030.
- Dunlay SM, Roger VL, Weston SA, Jiang R, Redfield MM.
Longitudinal changes in ejection fraction in heart failure patients
with preserved and reduced ejection fraction. Circ Heart Fail. 2012
Nov;5(6):720-6. doi: 10.1161/CIRCHEARTFAILURE.111.966366. Epub 2012
Aug 30. PMID: 22936826; PMCID: PMC3661289.
- Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA Guideline
for the Management of Heart failure: A Report of the American
College of Cardiology Foundation/American Heart Association Task
Force on Practice Guidelines. Circulation.
2013;128:e240-e327.
- Jhund PS, MacIntyre K, Simpson CR, et al. Long-Term Trends in
First Hospitalization for Heart Failure and Subsequent Survival
Between 1986 and 2003. Circulation. 2009;119:515-523.
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