Sage Therapeutics Inc. (NASDAQ: SAGE) shares absolutely exploded on Thursday after the firm announced top-line results from its late-stage trial in severe postpartum depression (PPD). Ultimately the Phase 3 clinical trials of brexanolone (formerly SAGE-547) achieved the primary endpoints in each.
PPD is a common biological complication of childbirth, affecting a subset of women typically commencing in the third trimester of pregnancy or within four weeks after giving birth. It is estimated that PPD affects roughly 10% to 20% of women giving birth in the United States and up to half of these cases may go undiagnosed without proper screening.
Currently, there are no approved therapies for PPD and there is a clear unmet medical need for treatment.
In the trial, patients treated with brexanolone demonstrated mean reductions from baseline in the Hamilton Rating Scale for Depression (HAM-D) total scores of 14 to 20 points at 60 hours maintained to 30 days in both trials. Brexanolone was generally well tolerated and showed a similar safety profile as seen in earlier studies.
Dr. Samantha Meltzer-Brody, M.D., MPH, associate professor and director of UNC Perinatal Psychiatry Program of the UNC Center for Women’s Mood Disorders and primary investigator of the studies, commented:
PPD is commonly viewed as a disorder solely experienced by the mother, but it also seriously impacts the child and family members – both immediate and extended. Symptoms of PPD should not be overlooked by new moms or those in their support networks and the healthcare community should encourage discussion and appropriate action. These data meaningfully advance our understanding of PPD and may prompt medical professionals to evaluate how PPD is perceived, identified and treated within their practices in the future. In these studies, brexanolone provided a profound and durable effect over the study period that could be an important step in potentially changing the way health care providers think about treating this disorder.
Shares of Sage were last seen up about 51% at $94.64, with a consensus analyst price target of $86.13 and a 52-week range of $44.55 to $96.99.