Cytokinetics Announces First Patient Dosed in Cohort 2 of Redwood-HCM
January 13 2021 - 7:30AM
Cytokinetics, Inc. (Nasdaq: CYTK) today announced that the first
patient has been dosed in Cohort 2 of REDWOOD-HCM
(
Randomized
Evaluation of
Dosing
With CK-274 in
Obstructive
Outflow
Disease in
HCM), an ongoing Phase
2 clinical trial of CK-3773274 (CK-274), a next-generation cardiac
myosin inhibitor in development for the potential treatment of
hypertrophic cardiomyopathy (HCM). This event triggers a $2.5
million milestone payment payable from Ji Xing Pharmaceuticals
Limited to Cytokinetics under the License and Collaboration
Agreement between the companies.
REDWOOD-HCM: Clinical Trial Design
REDWOOD-HCM is a multi-center, randomized,
placebo-controlled, double-blind, dose finding clinical trial of
CK-274 in patients with symptomatic obstructive HCM (oHCM). The
primary objective of the trial is to determine the safety and
tolerability of CK-274. The secondary objectives are to describe
the concentration-response relationship of CK-274 on the resting
and post-Valsalva left ventricular outflow tract gradient as
measured by echocardiography during 10 weeks of treatment, to
describe the dose response relationship of CK-274, and to evaluate
the plasma concentrations of CK-274 in patients with oHCM.
The trial will enroll two sequential cohorts,
with an option for a third cohort. Within each cohort,
approximately 18 patients will be randomized 2:1 to active or
placebo treatment and receive up to three escalating doses of
CK-274 or placebo based on echocardiographic guidance. Patients
receive an echocardiogram after two weeks of treatment at each dose
to determine whether they will be up-titrated. Overall, the
treatment duration will be 10 weeks with an echocardiogram to
confirm reversibility of effect 2-weeks after the last dose.
REDWOOD-HCM is expected to enroll patients in approximately 20
investigative sites in North America and Europe.
Interim analysis of data from Cohort 1 of
REDWOOD-HCM showed patients experienced substantial reductions in
the average resting left ventricular outflow tract gradient
(LVOT-G) as well as the post-Valsalva LVOT-G (defined as resting
gradient <30 mmHg and post-Valsalva gradient <50 mmHg). These
clinically relevant decreases in pressure gradients were achieved
with only modest decreases in average left ventricular ejection
fraction (LVEF); there were no dose interruptions due to LVEF
falling below 50%, the prespecified safety threshold.
Pharmacokinetic data were similar to those observed in Phase 1 in
healthy subjects. In addition, the safety and tolerability data
were supportive of continued dose escalation with no serious
adverse events attributed to study treatment reported by the
investigators.
The second cohort of REDWOOD-HCM is open for
enrollment in centers in North America and Europe. Enrollment in
Cohort 2 of REDWOOD-HCM is expected to complete in Q1 2021 and full
results from REDWOOD-HCM, across both Cohort 1 and Cohort 2, are
expected in mid-2021.
Additional information about REDWOOD-HCM can be
found on www.clinicaltrials.gov.
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. There are no FDA
approved medical treatments that directly address the
hypercontractility that underlies HCM.
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 preparing for regulatory
interactions for omecamtiv mecarbil, its novel cardiac muscle
activator, following positive results from GALACTIC-HF, a large,
international Phase 3 clinical trial in patients with heart
failure. 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 hypertrophic cardiomyopathies (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.
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.
About Ji Xing
Pharmaceuticals
Backed by RTW Investments, Ji Xing is a
privately held, leading Shanghai-based biotechnology company
committed to bringing innovative science and medicines to
underserved Chinese patients with serious and life-threatening
diseases.
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 timing, design and results
of Cytokinetics’ Phase 2 clinical trial of CK-274; the potential
benefits of CK-274; the ability to complete enrollment of Cohort 2
of REDWOOD-HCM in [the first quarter of] 2021 and the impact of the
COVID-19 pandemic on such enrollment (for further information
regarding the historical and potential prospective impact of the
COVID-19 pandemic on our business operations and clinical trials,
please refer to Cytokinetics’ Form 10-Q for the quarterly period
ended September 30, 2020); Cytokinetics’ and its partners’ research
and development activities; the timing of enrollment of patients in
Cytokinetics’ and its partners’ clinical trials; the design,
timing, results, significance and utility of preclinical and
clinical results; and the properties and potential benefits of
Cytokinetics’ 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; patient enrollment for or conduct
of clinical trials may be difficult or delayed; 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; Cytokinetics’
partners decisions with respect to research and development
activities; 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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