Three years into a PhIII program for a failed Duchenne MD drug, Catabasis hauls down the flag and admits defeat
Three years ago, Catabasis CEO Jill Milne and the crew insisted they had found good reason for great cheer once they plumbed the data from their failed study for the Duchenne MD drug edasalonexent. Plunging into the extended open-label data, they said, you could find solid evidence of efficacy. And that justified a try in Phase III.
But they were wrong.
Monday, after the bell, the little biotech acknowledged that their pivotal attempt following the mid-stage flop was another failure. The primary, change in baseline on the North Star Ambulatory Assessment, and the secondary on timed function tests both came up short of statistical significance.
And there’s no fourth act for this drug. Catabasis $CATB is killing the effort, including an open-label extension study.
Researchers recruited 131 boys for the study, large for this rare disease population.
Catabasis has $52 million in the bank. And it has one other drug in the pipeline, a preclinical program on autophagy. At the end of the trading day Monday, the biotech had a market cap of a little more than $100 million. After the bell, shares crumbled, sliding 64%.
It’s time to sound taps for this one.