After M&A hype and a small win for a midstage major depressive disorder test earlier this year, Sage Therapeutics has seen its shares soar. But today it was brought down to earth with a late-stage failure for brexanolone.
The med was being tested in the phase 3 ‘Status’ trial in 132 patients with super-refractory status epilepticus (SRSE), but it completely missed its primary endpoint, with brexanolone essentially matching a dummy treatment (43.9% vs 42.4%; p=0.8775) when added to standard-of-care.
Specifically, the med matched placebo in successfully weaning from third-line agents during the double-blind period, and remaining free of status epilepticus activity for at least the 24 hours following the end of treatment without the need to reinstate the third-line agents. “Secondary endpoint results were consistent with the primary endpoint,” the company added.
“I’m proud of the Sage team for the significant progress they have made in improving our understanding of how to best treat these critically ill patients,” said Jeff Jonas, M.D., CEO of Sage.
“SRSE is a complicated condition that is poorly understood, and I want to thank the patients, their families, and the investigators who participated in the Status trial. Although we did not meet the primary endpoint, this first-ever trial in a highly variable and complex patient population confirms that research in a critical care unit is possible and deepens our understanding of GABA mechanisms and their effect on brain circuitry.”
Back in February, it got a share boost after its major depressive disorder candidate SAGE-217 recently hit its marks in a small, phase 2 test. And last summer, it was also up 35% in early trading on positive top-line phase 2 data for patients with severe postpartum depression.
After its depression data Sage fuelled, and then dampened, its own M&A rumors after a Bloomberg interview that went a little awry.
Today’s setback will, however, hit the company hard in the short-term, and given the recent positives are from relatively small trials, questions over R&D platform and future will be put under the microscope.