Catabasis Pharmaceuticals to Present the MoveDMD Trial of Edasalonexent in Duchenne Muscular Dystrophy at the 24th Internatio...
September 27 2019 - 8:00AM
Business Wire
Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a clinical-stage
biopharmaceutical company, today announced that the Phase 2 MoveDMD
trial and open-label extension with edasalonexent in boys affected
by Duchenne muscular dystrophy (DMD) will be presented at the 24th
International Congress of the World Muscle Society, being held
October 1-5, 2019, at the Tivoli Garden Concert Hall in Copenhagen,
Denmark.
Dr. Richard Finkel, M.D., Chief, Division of Neurology,
Department of Pediatrics at Nemours Children’s Health System, and
Principal Investigator for the Phase 2 MoveDMD and Phase 3
PolarisDMD studies of edasalonexent in DMD will present “Treatment
of Young Boys with Duchenne Muscular Dystrophy with the NF-kB
Inhibitor Edasalonexent Showed a Slowing of Disease Progression as
Assessed by MRI and Functional Measures.” The presentation will
take place at the Concert Hall on Saturday, October 5th at 1pm
local time.
About Edasalonexent Edasalonexent (CAT-1004) is an
investigational oral small molecule designed to inhibit NF-kB that
is being developed as a potential foundational therapy for all
patients affected by DMD, regardless of their underlying mutation.
In DMD the loss of dystrophin leads to chronic activation of NF-kB,
which is a key driver of skeletal and cardiac muscle disease
progression. We are currently enrolling our global Phase 3
PolarisDMD trial to evaluate the efficacy and safety of
edasalonexent for registration purposes. Edasalonexent is also
being dosed in the open-label extension trial GalaxyDMD. In our
MoveDMD Phase 2 trial and open-label extension, we observed that
edasalonexent preserved muscle function and substantially slowed
disease progression compared to rates of change in a control
period, and significantly improved biomarkers of muscle health and
inflammation. The FDA has granted orphan drug, fast track, and rare
pediatric disease designations and the European Commission has
granted orphan medicinal product designation to edasalonexent for
the treatment of DMD. For a summary of clinical results, please
visit www.catabasis.com.
About Catabasis At Catabasis Pharmaceuticals, our mission
is to bring hope and life-changing therapies to patients and their
families. Our lead program is edasalonexent, an NF-kB inhibitor in
development for the treatment of Duchenne muscular dystrophy. The
global Phase 3 PolarisDMD trial is currently enrolling boys
affected by Duchenne. For more information on edasalonexent and our
Phase 3 PolarisDMD trial, please visit www.catabasis.com.
Forward Looking Statements Any statements in this press
release about future expectations, plans and prospects for the
Company, including statements about future clinical trial plans
including, among other things, statements about the Company’s
global Phase 3 PolarisDMD trial in DMD to evaluate the efficacy and
safety of edasalonexent for registration purposes, including the
anticipated timing for top-line results, potential timing for the
filing of an NDA, and other statements containing the words
“believes,” “anticipates,” “plans,” “expects,” “may” and similar
expressions, constitute forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those indicated by such
forward-looking statements as a result of various important
factors, including: uncertainties inherent in the initiation and
completion of preclinical studies and clinical trials and clinical
development of the Company’s product candidates; whether interim
results from a preclinical or clinical trial will be predictive of
the final results of the trial or the results of future trials;
expectations for regulatory approvals to conduct trials or to
market products; availability of funding sufficient for the
Company’s foreseeable and unforeseeable operating expenses and
capital expenditure requirements; other matters that could affect
the availability or commercial potential of the Company’s product
candidates; and general economic and market conditions and other
factors discussed in the “Risk Factors” section of the Company’s
Quarterly Report on Form 10-Q for the year ended June 30, 2019,
which is on file with the Securities and Exchange Commission, and
in other filings that the Company may make with the Securities and
Exchange Commission in the future. In addition, the forward-looking
statements included in this press release represent the Company’s
views as of the date of this press release. The Company anticipates
that subsequent events and developments will cause the Company’s
views to change. However, while the Company may elect to update
these forward-looking statements at some point in the future, the
Company specifically disclaims any obligation to do so. These
forward-looking statements should not be relied upon as
representing the Company’s views as of any date subsequent to the
date of this release.
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version on businesswire.com: https://www.businesswire.com/news/home/20190927005055/en/
Investor and Media Contact Andrea
Matthews Catabasis Pharmaceuticals, Inc. T: (617) 349-1971
amatthews@catabasis.com
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