Sage Therapeutics Inc. (NASDAQ: SAGE) saw its shares drop by almost a quarter early on Tuesday after the firm gave an update on its late-stage study trial in the treatment super-refractory status epilepticus (SRSE). Ultimately, the Phase 3 trial of brexanolone (SAGE-547) did not meet its primary endpoint and investors sent the shares lower.
The study found that 43.9% of patients treated with brexanolone, versus 42.4% of patients treated with placebo, successfully weaned from third-line agents during the double-blind period and remained 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.
This trial was conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) and was designed to evaluate the efficacy and safety of brexanolone in patients with SRSE.
In the double-blind trial, 132 patients were randomized to receive either brexanolone or placebo in addition to standard-of-care third-line antiseizure agents for six days. Patients who failed to respond to brexanolone or placebo were subsequently eligible for an open-label infusion of brexanolone at a higher dose over a six-day period.
Jeff Jonas, M.D., CEO of Sage, took a positive perspective on the trial and commented:
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. 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. As we continue examining data from the STATUS Trial in the coming weeks, I’m hopeful this information will inform current treatments, and aid in the development of future treatments for patients with SRSE.
Shares of Sage traded mid-morning Tuesday still down more than 16% to $74.00. The consensus analyst price target is $92.17, and the 52-week trading range is $38.30 to $90.80.