Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle
disease biopharmaceutical company, today announced the dosing of
the first patient in the Phase 2 CIRRUS-HCM trial of EDG-7500.
EDG-7500 is a novel oral, selective, cardiac sarcomere modulator,
specifically designed to slow early contraction velocity and
address impaired cardiac relaxation associated with HCM and other
diseases of diastolic dysfunction. The Phase 2 trial will assess
the safety, tolerability, pharmacokinetics (PK) and
pharmacodynamics of EDG-7500 in patients with obstructive HCM. Part
A of the trial will evaluate single doses and Part B will evaluate
multiple oral doses of EDG-7500 over 28 days.
“Based on the strength of clinical and preclinical data to-date,
we are advancing EDG-7500 into the Phase 2 CIRRUS-HCM trial in
patients with obstructive HCM,” said Marc Semigran, M.D., Chief
Development Officer, Edgewise Therapeutics. “We are encouraged by
the effects of EDG-7500 observed in a translatable preclinical
disease model of obstructive HCM. EDG-7500 demonstrated potent left
ventricular (LV) outflow tract gradient relief while maintaining
overall normal LV contractility. Importantly, in preclinical models
of non-obstructive HCM, both acute and chronic administration of
EDG-7500 has also been observed to be associated with significant
improvements in ventricular filling and diastolic function.”
Kevin Koch, Ph.D., President and Chief Executive Officer,
Edgewise Therapeutics added, “Advancing EDG-7500 into patients with
obstructive HCM is an important milestone for Edgewise. EDG-7500 is
representative of the robust discovery and development capabilities
at Edgewise and our commitment to patients with serious muscle
diseases.”
The Company expects to report data from the single dose arm of
this trial and a Phase 1 trial of EDG-7500 in healthy volunteers in
the third quarter of 2024. Furthermore, the Company expects to
initiate a 28-day trial in patients with obstructive and
non-obstructive HCM in the second half of 2024. The Company also
expects to begin an open-label extension trial of EDG-7500 in the
fourth quarter of 2024.
About the Phase 2 CIRRUS-HCM Trial
CIRRUS-HCM is a multi-center, two-part, open-label trial of
EDG-7500 in patients with obstructive HCM at up to 20 clinical
sites in the U.S. The trial will evaluate the safety, tolerability,
PK and pharmacodynamics of EDG-7500 in up to 30 adults with
obstructive HCM. Participants enrolled in this trial will receive
EDG-7500 as a single oral dose and may then receive multiple oral
doses over 28 days. To learn more about this trial (NCT06347159),
go to clinicaltrials.gov.
About Hypertrophic Cardiomyopathy
HCM is the most common form of genetic heart disease, affecting
approximately one in 200-500 individuals. HCM is caused by abnormal
proteins in the heart, including cardiac myosin, that lead to
excessive cardiac contraction, referred to as hypercontractility.
This disruption in cardiac muscle contractility leads to increased
stress and thickening of the walls of the major pumping chamber of
the heart, the LV. The LV becomes less compliant and therefore less
able to fill with and pump blood resulting in a decrease in the LV
chamber volume. Individuals with HCM can become extremely limited
in their functional capacity and ability to perform the activities
of daily living. In addition, these individuals are at increased
risk of heart failure, stroke, atrial fibrillation, and sudden
cardiac arrest. Despite advancements in the development of
therapies to treat HCM, there is currently a significant unmet need
for additional therapeutic approaches and options for patients.
About EDG-7500 for Hypertrophic Cardiomyopathy
EDG-7500 is a novel oral, selective, cardiac sarcomere
modulator, specifically designed to slow early contraction velocity
and address impaired cardiac relaxation associated with HCM and
other diseases of diastolic dysfunction. Preclinical data in models
of both obstructive and non-obstructive HCM suggest the ability to
drive a broadly effective clinical response at a low risk of
decreasing left ventricular ejection fraction below normal at all
doses tested. Based on EDG-7500’s self-limiting effect on systolic
contraction observed in preclinical models, the Company plans to
investigate fixed-dose regimens of EDG-7500, thus potentially
avoiding intensive safety monitoring of patients on current
therapy.
The Company is advancing a randomized, placebo-controlled,
single and multiple ascending dose Phase 1 trial (NCT06011317)
evaluating safety, tolerability, PK and pharmacodynamics in healthy
adults. The Company recently initiated the Phase 2 CIRRUS-HCM trial
to evaluate the safety, tolerability, PK and pharmacodynamics of
EDG-7500 in patients with obstructive HCM. To learn more about this
trial (NCT06347159), go to clinicaltrials.gov.
About Edgewise Therapeutics
Edgewise Therapeutics is a leading muscle disease
biopharmaceutical company developing novel therapeutics for
muscular dystrophies and serious cardiac conditions. The Company’s
deep expertise in muscle physiology is driving a new generation of
novel therapeutics. Sevasemten is an orally administered skeletal
myosin inhibitor in late-stage clinical trials in Becker and
Duchenne muscular dystrophies. EDG-7500 is a novel cardiac
sarcomere modulator for the treatment of hypertrophic
cardiomyopathy and other diseases of diastolic dysfunction,
currently in Phase 2 clinical development. The entire team at
Edgewise is dedicated to our mission: changing the lives of
patients and families affected by serious muscle diseases. To learn
more, go to: www.edgewisetx.com or follow us on LinkedIn, X
(formerly Twitter), Facebook, Instagram and Threads.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as that
term is defined in Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. Statements in
this press release that are not purely historical are
forward-looking statements. Such forward-looking statements
include, among other things, statements regarding the potential of,
and expectations regarding EDG-7500; statements regarding the
timing of reporting data (including the single dose arm of the
Phase 2 CIRRUS-HCM Trial of EDG-7500 and Phase 1 trial of EDG-7500
in healthy volunteers); statements regarding Edgewise’s
expectations relating to its clinical trials, including the
commencement of trials (including the Phase 2 trial of EDG-7500 in
individuals with obstructive and non-obstructive HCM and open-label
extension trial of EDG-7500); and statements by Edgewise’s
president and chief executive officer and chief development
officer. Words such as “believes,” “anticipates,” “plans,”
“expects,” “intends,” “will,” “goal,” “potential” and similar
expressions are intended to identify forward-looking statements.
The forward-looking statements contained herein are based upon
Edgewise’s current expectations and involve assumptions that may
never materialize or may prove to be incorrect. Actual results
could differ materially from those projected in any forward-looking
statements due to numerous risks and uncertainties, including but
not limited to: risks associated with the process of discovering,
developing and commercializing drugs that are safe and effective
for use as human therapeutics and operating as an early clinical
stage company including the potential for Edgewise’s product
candidates to cause serious adverse events; Edgewise’s ability to
develop, initiate or complete preclinical studies and clinical
trials for, obtain approvals for and commercialize any of its
product candidates; the timing, progress and results of preclinical
studies and clinical trials for EDG-7500; Edgewise’s ability to
raise any additional funding it will need to continue to pursue its
business and product development plans; the timing, scope and
likelihood of regulatory filings and approvals; the potential for
any clinical trial results to differ from preclinical, interim,
preliminary, topline or expected results; the potential that the
outcome of preclinical testing and early clinical trials may not be
predictive of the success of later clinical trials; Edgewise’s
ability to develop a proprietary drug discovery platform to build a
pipeline of product candidates; Edgewise’s manufacturing,
commercialization and marketing capabilities and strategy; the size
of the market opportunity for Edgewise’s product candidates; the
loss of key scientific or management personnel; competition in the
industry in which Edgewise operates; Edgewise’s reliance on third
parties; Edgewise’s ability to obtain and maintain intellectual
property protection for its product candidates; general economic
and market conditions; and other risks. Information regarding the
foregoing and additional risks may be found in the section entitled
“Risk Factors” in documents that Edgewise files from time to time
with the U.S. Securities and Exchange Commission. These
forward-looking statements are made as of the date of this press
release, and Edgewise assumes no obligation to update the
forward-looking statements, or to update the reasons why actual
results could differ from those projected in the forward-looking
statements, except as required by law.
This press release contains hyperlinks to information that is
not deemed to be incorporated by reference into this press
release.
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version on businesswire.com: https://www.businesswire.com/news/home/20240506327325/en/
Edgewise Contacts Investors: Michael Carruthers,
Chief Financial Officer ir@edgewisetx.com
Media: Maureen Franco, VP Corporate Communications
media@edgewisetx.com
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