Edgewise Therapeutics Highlights 2023 Accomplishments and Anticipated Milestones for 2024 at the 42nd Annual J.P. Morgan Healthcare Conference
09 Enero 2024 - 7:39AM
Business Wire
Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle
disease biopharmaceutical company, will present today at the 42nd
Annual J.P. Morgan Healthcare Conference at 10:30 am PT (1:30 pm
ET), and a live webcast will be available at www.edgewisetx.com.
Ahead of the presentation, the Company highlighted its 2023
accomplishments and announced its anticipated key milestones for
2024.
“In 2023, we had tremendous progress in the clinic advancing our
novel oral therapeutics that are designed to treat severe muscle
conditions,” said Kevin Koch, Ph.D., President and Chief Executive
Officer of Edgewise. “We are well positioned to execute on our 2024
milestones including important EDG-5506 data in muscular
dystrophies, first-in-human studies in our EDG-7500 cardiac
program, as well as preclinical exploration of novel
cardiometabolic targets.”
2023 Accomplishments
Musculoskeletal Program –
EDG-5506
Becker muscular dystrophy (Becker)
- Announced positive 12-month open label ARCH trial data. ARCH is
an open label, single-center study assessing the safety,
tolerability, impact on muscle damage biomarkers, function and
pharmacokinetics (PK) of EDG-5506 in adults with Becker.
- Over-enrolled the Phase 2 CANYON placebo-controlled cohorts
with 40 adults and 29 adolescents.
- Initiated GRAND CANYON, a global pivotal cohort in individuals
with Becker. GRAND CANYON is a multicenter, randomized,
double-blind, placebo-controlled study to evaluate the safety and
efficacy of EDG-5506 in adults with Becker.
- Initiated Phase 2 open-label extension MESA trial that will
assess the long-term effect of EDG-5506 on safety, biomarkers and
functional measures. MESA will provide continued access to EDG-5506
treatment to study participants who were previously enrolled in
Edgewise studies.
- Advanced Phase 2 DUNE exercise challenge study to evaluate the
effect of EDG-5506 on biomarkers of muscle damage following
controlled exercise in adults with Becker, Limb Girdle muscular
dystrophy2I/R9 or McArdle disease.
- U.S. Food & Drug Administration (FDA) granted EDG-5506
Orphan Drug Designation for the treatment of Becker.
Duchenne muscular dystrophy (Duchenne)
- Rapidly enrolled and expanded Phase 2 LYNX placebo-controlled
trial in children aged 4 to 9 years with Duchenne. LYNX will assess
the effect of multiple doses of EDG-5506 over 12 weeks on safety,
PK and biomarkers of muscle damage. Participants will then continue
in an open-label extension portion of the trial for a total of 24
months to gain further insights into safety and functional
measures.
- Initiated Phase 2 FOX placebo-controlled trial that will assess
the effect of EDG-5506 over 12 weeks on safety, PK and biomarkers
of muscle damage in children and adolescents with Duchenne who have
been previously treated with gene therapy. Participants will then
continue in an open-label extension portion of the trial for a
total of 12 months to gain further insights into safety, PK,
function and biomarker measures.
- FDA granted EDG-5506 Rare Pediatric Disease Designation for the
treatment of Duchenne.
- FDA granted EDG-5506 Orphan Drug Designation for the treatment
of Duchenne.
Cardiac Program –
EDG-7500
Hypertrophic Cardiomyopathy (HCM)
- Expanded the pipeline to include EDG-7500, a first-in-class
cardiac sarcomere modulator, specifically designed to slow early
contraction velocity and address impaired cardiac relaxation
associated with HCM and other diseases of diastolic
dysfunction.
- Initiated first-in-human Phase 1 trial of EDG-7500, a
randomized, double-blind, placebo-controlled, single and multiple
ascending dose study evaluating safety, tolerability, PK and
pharmacodynamics in healthy adults.
Anticipated 2024 Key
Milestones
Musculoskeletal Program –
EDG-5506
Becker muscular dystrophy
- Report 24-month data from the open label ARCH trial in the
first half of 2024.
- Continue to advance the Phase 2 CANYON placebo-controlled
study, announce 1-year data in the second half of 2024.
- Announce Phase 2 DUNE (Becker, LGMD, McArdle) exercise
challenge data in the first half of 2024.
Duchenne muscular dystrophy
- Continue to advance Phase 2 LYNX trial, announce 3-month
controlled dose-ranging data in the first half of 2024.
- Pending data from ongoing EDG-5506 studies, initiate Phase 3
trial in the second half of 2024.
Cardiac Program –
EDG-7500
Hypertrophic Cardiomyopathy
- Announce Phase 1 data in healthy volunteers and individuals
with obstructive hypertrophic cardiomyopathy in the second half of
2024.
Presentation at the 42nd Annual J.P.
Morgan Healthcare Conference
Edgewise will webcast its presentation today from the J.P.
Morgan 42nd Annual Healthcare Conference at 10:30 am PT (1:30 pm
ET). To access the live webcast, please visit the Edgewise events
page at https://investors.edgewisetx.com/. A replay of the webcast
will be available on Edgewise’s website for a limited time
following the conference.
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 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, Edgewise’s product candidates and
programs, including EDG-5506 and EDG-7500; statements regarding
Edgewise’s expectations relating to its clinical trials, including
timing of reporting data (including the 24-month data from the open
label ARCH trial, the 1-year data for the Phase 2 CANYON trial; the
Phase 2 DUNE data; the 3-month data for the Phase 2 LYNX trial; and
the Phase 1 data for the EDG-7500 cardiac program) and commencement
of trials (including the Phase 3 trial for EDG-5506); the
possibility of data from GRAND CANYON to support a marketing
application; statements regarding Edgewise’s pipeline of product
candidates and programs; statements regarding Edgewise’s
anticipated 2024 milestones; and statements by Edgewise’s President
and Chief Executive 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
clinical trials for, obtain approvals for and commercialize any of
its product candidates; Edgewise’s ability to take advantage of
potential benefits associated with designations granted by FDA
and/or to maintain qualifications for applicable designations over
time; the timing, progress and results of clinical trials for
EDG-5506 and EDG-7500; Edgewise’s ability to enroll and maintain
patients in clinical trials; 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.
This press release contains hyperlinks to information that is
not deemed to be incorporated by reference into this press
release.
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Edgewise
Investors: Michael Carruthers, Chief Financial
Officer ir@edgewisetx.com
Media: Maureen Franco, VP Corporate Communications
media@edgewisetx.com
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