CAMBRIDGE, Mass.--(BUSINESS WIRE)--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 Catabasis
At 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 Statements
Any 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.
