Catabasis slashes 42% of staff to 'focus resources' on edasalonexent

Catabasis says it is preparing for a phase 3 registration trial, but that is "dependent on raising capital." (M. Roth)

Catabasis Pharmaceuticals is laying off 21 employees, or 42% of its staff, in a restructuring that will throw its resources behind its lead asset, the Duchenne muscular dystrophy drug edasalonexent.

The Cambridge, Massachusetts, biotech expects to finish the overhaul in the second quarter, it said in a statement. It will cost about $1 million in severance and related costs, but will save the company about $3.3 million per year in the long run.

“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 Catabasis CEO Jill Milne, Ph.D., in the statement.

“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 an oral NF-kB inhibitor and, unlike other DMD treatments, such as Sarepta's Exondys 51, could potentially be used in patients regardless of their underlying mutation, the company says.

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Catabasis had its first big setback in summer 2016, when its hypercholesterolemia failed to lower LDL in a midstage trial. Things started looking up the following January, when phase 1 data indicated edasalonexent was safe when given to adults and reduced levels of NF-kB. But it all came crashing down barely two weeks later, when topline phase 2 data showed the drug failed to beat placebo in 31 Duchenne patients with the measure of change in lower leg muscles. Catabasis shares plummeted 65%.

Last October, the biotech posted the last of the phase 2 data, saying it planned to launch a phase 3 trial in the first half of 2018 that is expected to read out in 2020. Now, the company says it’s preparing for the trial, for registration purposes, but only if it raises enough capital.