Edgewise Therapeutics Begins Dosing First-in-Human Phase 1 Trial of EDG-7500, its Lead Clinical Candidate for Hypertrophic Cardiomyopathy (HCM) and Other Serious Diseases of Cardiac Diastolic Dysfunction
14 September 2023 - 10:00PM
Business Wire
– EDG-7500 is a first-in-class oral, selective,
cardiac sarcomere modulator that has the potential to benefit a
broad spectrum of HCM and other cardiomyopathy patients –
Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle
disease biopharmaceutical company, today announced initial dosing
in a Phase 1 trial of EDG-7500. EDG-7500 is a first-in-class 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 1 trial will assess the safety,
tolerability, pharmacokinetics and pharmacodynamics of EDG-7500 in
healthy adults. The Company is also planning to begin a Phase 1b
study of EDG-7500 in individuals with obstructive HCM in the first
half of 2024.
“Initiation of our Phase 1 study of EDG-7500, our first
cardiovascular therapeutic candidate, is an important milestone for
our company,” said Marc Semigran, M.D., Chief Development Officer,
Edgewise Therapeutics. “I have spent over 30 years working to help
patients with serious heart disease and am excited about the
potential of EDG-7500 to help individuals affected by HCM, where
significant unmet needs remain.”
Kevin Koch, Ph.D., President and Chief Executive Officer,
Edgewise Therapeutics added, “We are pleased to add EDG-7500 to our
growing clinical pipeline demonstrating our commitment to
developing precision therapies for patients with severe genetic
muscle diseases. EDG-7500 is representative of the robust discovery
and development capabilities at Edgewise, and our commitment to
patients with serious skeletal and cardiac muscle diseases. As we
mark this achievement, we look forward to initiating trials next
year in HCM, and broadly in disorders of diastolic
dysfunction.”
About EDG-7500 Phase 1 Clinical Trial
The Phase 1 trial is a randomized, double-blind,
placebo-controlled, single and multiple ascending dose study
evaluating the safety, tolerability, pharmacokinetics and
pharmacodynamics of EDG-7500 in healthy adults. Participants
enrolled in this study will receive a single oral dose or multiple
oral doses of EDG-7500 or a placebo. To learn more about this study
(NCT06011317), go to clinicaltrials.gov.
About Hypertrophic Cardiomyopathy
HCM is the most common form of genetic heart disease with an
estimated prevalence of as many as 700,000 people in the United
States. The molecular underpinnings of HCM lead to abnormal cardiac
sarcomeric protein function that eventually results in excessive
contraction of the heart muscle, referred to as hypercontractility.
Over time, hypercontractility increases the thickness (hypertrophy)
of the heart’s left ventricular (LV) walls – the heart’s primary
pumping chamber. Progressive hypertrophy eventually leads to a
thick and stiff LV thereby reducing its ability to fill with blood
during relaxation (diastole) and pump blood during contraction
(systole). A decreased volume of blood entering and leaving the LV
causes shortness of breath, rapid heartbeat, chest pain,
unexplained fatigue, dizziness, and syncope (loss of
consciousness), which together cause HCM patients to become limited
in their ability to perform activities of daily living. HCM can be
diagnosed at any age; disease progression increases the risk of
heart failure, stroke and atrial fibrillation. Despite advancements
in the development of therapies to treat HCM, there is currently a
significant unmet need for additional therapies to safely and more
effectively treat the disease.
About EDG-7500 for HCM
EDG-7500 is a first-in-class oral, selective, cardiac sarcomere
modulator that is advancing in a Phase 1 trial. The compound is
designed to slow early contraction velocity and improve impaired
cardiac relaxation. This novel mechanism is anticipated to have a
broad therapeutic index that may facilitate fixed patient dosing
and minimize monitoring during therapy. Preclinical data of
EDG-7500 support beneficial activity in animal models of both
obstructive HCM and cardiac diastolic dysfunction with minimal
changes in left ventricular systolic performance. The Company plans
to present preclinical data of EDG-7500 at a major cardiovascular
meeting later this year.
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
first-in-class therapeutics. EDG-5506 is an orally administered
skeletal myosin inhibitor in advanced clinical trials in patients
with Becker, Duchenne, and Limb-Girdle muscular dystrophies as well
as McArdle Disease. EDG-7500, currently in a Phase 1 trial, is a
novel cardiac sarcomere modulator for the treatment of HCM and
other disorders of cardiac diastolic dysfunction. 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
Edgewise’s expectations relating to its preclinical studies and
clinical trials, including the commencement of trials (including
the Phase 1b study of EDG-7500 in individuals with obstructive
HCM); 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; 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.
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Investors & Media Michael Carruthers Chief Financial
Officer ir@edgewisetx.com
Edgewise Therapeutics (NASDAQ:EWTX)
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