Catabasis Pharmaceuticals Aligns Resources to Focus on Lead Program Edasalonexent for the Treatment of Duchenne Muscular Dyst...
18 April 2018 - 6:01AM
Business Wire
-- Strategic Corporate Restructuring Supports
Goal of Advancing Edasalonexent Towards Potential Registration
--
Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a clinical-stage
biopharmaceutical company, today announced a restructuring of the
organization to focus resources on the Company’s late-stage lead
program, edasalonexent for the treatment of Duchenne muscular
dystrophy (DMD). Catabasis is prioritizing this program to deliver
against its goal of bringing a life changing therapy to those
affected by Duchenne.
“This decision best positions us to achieve success with our
most advanced program to help Duchenne patients and to support the
long-term growth of Catabasis. However, on a personal level, this
decision was difficult and I want to thank the talented and
dedicated colleagues who are affected for their hard work and
commitment to our mission,” said Jill C. Milne, Ph.D., Chief
Executive Officer of Catabasis. “Based on disease-slowing data from
our MoveDMD trial, we believe edasalonexent can make a significant
difference in the lives of boys affected by Duchenne. These
important corporate changes will allow us to focus our resources on
continuing to advance edasalonexent and improving the lives of boys
affected by this devastating disease.”
Edasalonexent is being developed as a potential
disease-modifying therapy for all patients affected by DMD,
regardless of their underlying mutation. In the Phase 2 MoveDMD
trial and open-label extension, edasalonexent has demonstrated
consistent and sustained slowing of disease progression in boys
with DMD through more than a year of treatment compared to the
off-treatment control period. No evidence of side effects or safety
issues common with the current DMD standard of care have been
observed after more than 37 patient-years of exposure to
edasalonexent. Catabasis is preparing for a single global Phase 3
trial to evaluate the efficacy and safety of edasalonexent for
registration purposes, dependent on raising capital.
The restructuring will reduce the Company’s workforce by
approximately 42%. As a result of the program focusing and
corresponding workforce restructuring, which is anticipated to be
completed in the second quarter of 2018, Catabasis estimates
annualized savings of approximately $3.3 million in
personnel-related costs, with estimated one-time severance and
related costs of approximately $1.0 million in the second quarter
of 2018.
About Edasalonexent (CAT-1004)Edasalonexent (CAT-1004) is
an investigational oral small molecule that is being developed as a
potential disease-modifying therapy for all patients affected by
DMD, regardless of their underlying mutation. Edasalonexent
inhibits NF-kB, a protein that is activated in DMD and drives
inflammation and fibrosis, muscle degeneration and suppresses
muscle regeneration. Edasalonexent continues to be dosed in the
open-label extension of the MoveDMD Phase 2 clinical trial and
Catabasis is preparing for a single global Phase 3 trial to
evaluate the efficacy and safety of edasalonexent for registration
purposes, dependent on raising capital. 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 reported to-date, please visit
www.catabasis.com.
About CatabasisAt Catabasis Pharmaceuticals, our mission
is to bring hope and life-changing therapies to patients and their
families. Our SMART (Safely Metabolized And Rationally Targeted)
Linker drug discovery platform enables us to engineer molecules
that simultaneously modulate multiple targets in a disease. Our
lead program in development is edasalonexent for the treatment of
Duchenne muscular dystrophy. For more information on edasalonexent
and our pipeline of drug candidates, please
visit www.catabasis.com.
Forward Looking StatementsAny statements in this press
release about future expectations, plans and prospects for the
Company, including statements about the expected cost of the
Company’s strategic restructuring, the Company’s expected future
savings from the restructuring, the timing and completion of the
restructuring, future clinical trial plans, 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 regarding whether the
Company will be able to implement the restructuring in a timely
fashion and at the level of expense projected, whether the Company
will be able to effectively manage the organizational changes
brought about by the restructuring and have sufficient capital
resources to fund its continuing operations in future periods to
realize its anticipated cost savings; uncertainties inherent in the
initiation and completion of clinical trials and clinical
development of the Company’s product candidates; the Company’s
ability to obtain financing on acceptable terms and in a timely
manner to fund the Company’s planned Phase 3 trial of edasalonexent
in DMD for registration purposes; 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 Annual Report on Form 10-K for the year
ended December 31, 2017, 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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Investor and Media ContactCatabasis
Pharmaceuticals, Inc.Andrea Matthews,
617-349-1971amatthews@catabasis.com
Catabasis Pharmaceuticals (NASDAQ:CATB)
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