Catabasis is prioritizing this program to deliver against its goal of bringing a life changing therapy to those affected by Duchenne.
Catabasis CEO Jill Milne said: “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.
“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.
Source: Company Press Release.