Cytokinetics Announces Initiation of Phase 1 Study of Aficamten in Healthy Japanese Participants
June 17 2024 - 7:30AM
Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the
first participants have been dosed in a Phase 1 study evaluating
the pharmacokinetics, safety and tolerability of aficamten in
healthy Japanese and Caucasian participants.
“We are conducting this Phase 1 bridging
study to characterize the pharmacokinetics of aficamten in healthy
Japanese adults and to gather evidence that we believe will be
required for potential approval in Japan,” said Fady I. Malik,
M.D., Ph.D., Cytokinetics’ Executive Vice President of Research
& Development. “In parallel, we are continuing to execute on
our later-stage global clinical development program for aficamten
alongside preparing regulatory submissions in the U.S. and
Europe which we expect to submit this year.”
Phase 1 Clinical Trial
Design
The primary objective of this Phase 1
double-blind, randomized, placebo-controlled study
is to evaluate the pharmacokinetics of aficamten following
administration of single ascending doses and multiple doses in 70
healthy Japanese and Caucasian participants. The secondary
objective is to evaluate the safety and tolerability of aficamten
in healthy Japanese and Caucasian participants. The study will
enroll four cohorts including three single-ascending cohorts and
one multiple dose cohort. Cohorts 1, 2 and 3 will enroll 10
Japanese participants and 10 Caucasian participants each,
randomized on an 8:2 basis to receive single-ascending doses of
aficamten (5 mg, 10 mg and 20 mg, respectively) or placebo.
Enrollment of Cohort 2 and Cohort 3 will commence upon evaluation
of the safety of the preceding Cohort. Following the completion of
the single ascending dose cohorts, Cohort 4 will enroll 10 healthy
Japanese participants randomized on an 8:2 basis to receive single
doses of aficamten (5 mg) or placebo, once daily for 14 days.
About
Aficamten
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
potential long-term effects on cardiac structure and function.
Aficamten was evaluated in SEQUOIA-HCM
(Safety, Efficacy, and
Quantitative Understanding of
Obstruction Impact of
Aficamten in HCM), a positive
pivotal Phase 3 clinical trial in patients with symptomatic
obstructive hypertrophic cardiomyopathy (HCM). Aficamten received
Breakthrough Therapy Designation for the treatment of symptomatic
obstructive HCM from the U.S. Food & Drug Administration (FDA)
as well as the National Medical Products Administration (NMPA) in
China. Cytokinetics expects to submit a New Drug Application (NDA)
to the FDA in Q3 2024 and a Marketing Authorization Application
(MAA) to the European Medicines Agency (EMA) in Q4 2024.
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, and 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.
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 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.
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. Cytokinetics continues its longstanding 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 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
properties or potential benefits of aficamten or any of our other
drug candidates, our ability to file a new drug application for
aficamten with FDA in third quarter 2024, our ability to file a
marketing authorization application for aficamten with EMA in the
fourth quarter 2024, our ability to obtain regulatory approval for
aficamten for the treatment of obstructive hypertrophic
cardiomyopathy or any other indication from FDA or any other
regulatory body in the United States or abroad, and the labeling or
post-marketing obligations that may be required by FDA or any other
regulatory body in the United States or abroad as a condition to
regulatory approval. 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
the risks related to Cytokinetics’ business outlines in
Cytokinetics’ filings with the Securities and Exchange Commission.
Forward-looking statements are not guarantees of future
performance, and Cytokinetics’ actual results of operations,
financial condition and liquidity, and the development of the
industry in which it operates, may differ materially from the
forward-looking statements contained in this press release. Any
forward-looking statements that Cytokinetics makes in this press
release speak only as of the date of this press release.
Cytokinetics assumes no obligation to update its forward-looking
statements whether as a result of new information, future events or
otherwise, after the date of this press release.
Contact:Cytokinetics Diane WeiserSenior Vice President,
Corporate Affairs(415) 290-7757
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