Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle
disease biopharmaceutical company, today announced its
participation at the 29th International Annual Congress of the
World Muscle Society (WMS) with an industry-sponsored symposium and
the presentation of seven scientific posters. These presentations
will highlight the effects of sevasemten in individuals with Becker
based on findings from the DUNE and ARCH clinical trials, as well
as provide perspectives on biomarker and functional endpoints being
studied in the CANYON Phase 2 trial. Sevasemten is an orally
administered small molecule designed to prevent contraction-induced
muscle damage in muscular dystrophies including Becker and Duchenne
muscular dystrophy. The conference will take place at The Prague
Congress Centre in Prague, Czechia, October 8-12, 2024.
Details of the Edgewise symposium and scientific posters at
WMS:
Edgewise Symposium with Key Opinion
Leaders
Date: Tuesday, October 8, 2024, at 4:30 pm CEST
Title: Understanding disease progression and a potential
novel agent to protect muscle
Presenters: Luca Bello, M.D., Ph.D, Associate
Professor, Department of Neurosciences, DNS, University of Padova
and Craig McDonald, M.D., Professor and Chair, Department of
Physical Medicine & Rehabilitation, Professor of Pediatrics,
Director MDA Neuromuscular Disease Clinics, University of
California Davis.
The symposium will also include discussion of the positive
two-year topline results from the ARCH trial, an open label,
single-center study assessing safety, tolerability, impact on
muscle damage biomarkers, pharmacokinetics (PK) and functional
measures with sevasemten in adults with Becker. Only registered
conference attendees can register for the symposium.
Scientific Posters
Title: Sevasemten, a fast myosin inhibitor, in adults
with Becker muscular dystrophy results in reduced muscle damage
biomarkers and functional stabilization (351P)
Title: Rasch evaluation of North Star Ambulatory
Assessment and North Star Assessment for Limb-Girdle Type Muscular
Dystrophies in Becker muscular dystrophy (322P)
Title: Exploring the content validity of patient-reported
outcome (PRO) measures to capture the patient experience of Becker
Muscular Dystrophy (BMD) (339P)
Title: Comparison of short- and long-term proteomic
response to the fast skeletal myosin inhibitor, sevasemten
(EDG-5506), in Becker muscular dystrophy (BMD) (349P)
Title: Protein biomarkers of muscle injury exhibit
differential reduction with subject age in adults with Becker
muscular dystrophy (729LBP)
Title: Post-exercise biomarkers of muscle injury are
reduced by sevasemten, a fast myosin inhibitor, in adults with
Becker muscular dystrophy (732LBP)
Title: Clinical trial readiness in rare and underserved
disease: learnings from community engagement and the lived
experience in Becker muscular dystrophy (Becker) (708LPB)
All Edgewise posters are being presented on Friday, October 11,
2024, in Poster Session 4 (Forum Hall) from 3:45 to 4:45 pm CEST.
The full WMS Congress program is available here.
The Edgewise symposium presentation and posters will be
available on the Edgewise website.
About Sevasemten for Becker and Duchenne Muscular
Dystrophies
Sevasemten is an orally administered small molecule designed to
prevent contraction-induced muscle damage in dystrophinopathies
including Becker and Duchenne. Sevasemten presents a novel
mechanism of action designed to selectively limit the exaggerated
muscle damage caused by the absence or loss of functional
dystrophin. By minimizing the progressive muscle damage that leads
to functional impairment, sevasemten has the potential to benefit a
broad range of patients suffering from debilitating neuromuscular
disorders.
In Becker, after completion of the two-year Phase 1 ARCH trial,
the Company continues to advance sevasemten through the clinic with
the Phase 2 CANYON trial, which is fully enrolled, evaluating
safety and effects on function and biomarkers of muscle damage in
adult males with Becker. The Company expects to report CANYON data
in the fourth quarter of 2024. The CANYON trial has expanded to
include an additional 120 adult participants in a pivotal cohort
GRAND CANYON, which is currently enrolling in the United States,
Europe, Israel, Australia and New Zealand. Data from GRAND CANYON,
if positive, could support a marketing application.
In Duchenne, the Company is advancing its Phase 2 clinical
trials, LYNX, assessing safety, pharmacokinetics and biomarkers of
muscle damage, and FOX, which includes children and adolescents
previously treated with gene therapy. The Company expects to report
LYNX data in the fourth quarter of 2024. The Company will rely on
LYNX data, along with data from the FOX trial of Duchenne children
previously treated with gene therapy, to guide the design and
powering of a Phase 3 trial in Duchenne, planned to be initiated in
the first half of 2025.
For more information on Edgewise’s clinical trials
https://edgewisetx.com/science-pipeline/clinical-trials/.
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,
Facebook and Instagram.
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 sevasemten; statements regarding the
timing of reporting data (including the data from the CANYON trial
and the LYNX trial); statements regarding Edgewise’s expectations
relating to its clinical trials (including the CANYON trial, GRAND
CANYON trial, LYNX trial and FOX trial); statements regarding the
data from GRAND CANYON being able to support a marketing
application; and statements regarding the commencement of trials
(including the Phase 3 trial of sevasemten in Duchenne). 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 Edgewise’s limited operating history, its products being early
in development and not having products approved for commercial
sale; risks associated with Edgewise not having generated any
revenue to date; Edgewise’s ability to achieve objectives relating
to the discovery, development and commercialization of its product
candidates, if approved; Edgewise’s need for substantial additional
capital to finance its operations; Edgewise’s substantial
dependence on the success of its sevasemten; Edgewise’s ability to
develop and commercialize sevasemten and discover, develop and
commercialize product candidates in future programs; risks related
to Edgewise’s clinical trials of its product candidates not
demonstrating safety and efficacy; risks related to Edgewise’s
product candidates causing serious adverse events, toxicities or
other undesirable side effects; the outcome of preclinical testing
and early clinical trials not being predictive of the success of
later clinical trials and the risks related to the results of
Edgewise’s clinical trials not satisfying the requirements of
regulatory authorities; delays or difficulties in the enrollment
and/or maintenance of patients in clinical trials; risks related to
failure to capitalize on other indications or product candidates;
risks related to competition; risks relating to interim, topline
and preliminary data from Edgewise’s clinical trials changing as
more patient data becomes available; risks related to the
regulatory approval processes being lengthy, time consuming and
inherently unpredictable; risks related to regulatory authorities
not accepting data from trials conducted in locations outside of
their jurisdiction; risks relating to Edgewise’s ability to attract
and retain highly skilled executive officers and employees;
Edgewise’s ability to obtain and maintain intellectual property
protection for its product candidates; Edgewise’s reliance on third
parties; 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/20241001999394/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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