Secondary data indicate further efficacy of SAGE-547 for postpartum depression

Sage Therapeutics announced positive findings for secondary endpoints of a phase 2 clinical trial assessing safety and efficacy of SAGE-547, an IV treatment for postpartum depression, among women who developed severe depression during or following childbirth.

“Postpartum depression [PPD] represents a severely understudied and underdiagnosed class of patients. PPD is currently estimated to affect between 500,000 and 750,000 mothers in the United States each year,” Stephen J. Kanes, MD, PhD, chief medical officer of Sage Therapeutics, said in a press release. “The unmet need for treatment in this vulnerable patient is significant. PPD carries an increased risk for suicide and it is one of the strongest predictors of suicidal ideation in new mothers.”

Stephen J. Kanes

In early September 2016, the FDA granted Breakthrough Therapy Designation to SAGE-547 for treatment of postpartum depression.

Secondary endpoints were assessed in a phase 2, multi-center, placebo-controlled, double-blind, 1:1 randomization trial among 21 women with severe postpartum depression that developed either in the third trimester or within 4 weeks of childbirth. At baseline, Hamilton Rating Scale for Depression (HAM-D) scores were greater than 28 among all study participants.

Edinburgh Perinatal Depression Scale (EPDS) and the Patient Health Questionnaire (PHQ-9) scores improved over 30 days among women who received SAGE-547, indicating a lasting treatment effect for more than 3 weeks following the end of treatment.

Specifically, mean change in EPDS scores from baseline to 30 days was –13.5 among women who received SAGE-547, compared with –5.3 among those who received placebo (P = .024).

At day 30, six patients (60%) of the SAGE-547 group had a score of 0 to 4 on the PHQ-9, compared with one patient in the placebo group.

Montgomery-Åsberg Depression Rating Scale (MADRS) scores and remission, indicated by HAM-D scores less than 7, statistically significantly improved among the SAGE-547 group.

As a result of these findings, Sage Therapeutics expanded its SAGE-547 development program by initiating two additional multi-center placebo-controlled trials. These include a dose-ranging study among women with severe postpartum depression and an efficacy study among those with moderate postpartum depression.

Results from these additional studies are expected in 2017, according to the release.

“The results of the secondary endpoints in this Phase 2 study of SAGE-547, including the Edinburgh Perinatal Depression Scale and PHQ-9, support the primary endpoints achieved in the trial. Data from this clinical program show improvement in the SAGE-547 group compared with placebo and the secondary endpoints are suggestive of improvement through 30 days in the SAGE-547 treatment group,” Kanes said in the release. “These collective findings have the potential to create a paradigm shift in how PPD is thought about and — if our program is successful — how PPD might be treated in the future.”