Sage Therapeutics' SAGE-217 hits main goal of late-stage postpartum depression study

Shares in Sage Therapeutics jumped more than 50 percent Monday after the company announced that a Phase III study of SAGE-217 in women with postpartum depression (PPD) met its primary endpoint, with the experimental oral drug significantly improving depressive symptoms versus placebo after two weeks of treatment. The company indicated that SAGE-217 was generally well tolerated, with overall reports of adverse events similar between the drug and placebo.  

The late-stage ROBIN trial randomised 151 adult female patients diagnosed with severe PPD to receive SAGE-217 or placebo, with the main goal assessed by the change from baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score at day 15. Secondary endpoints included changes in the Montgomery-Åsberg Depression Rating Scale (MADRS), Hamilton Anxiety Rating Scale (HAM-A) and Clinical Global Impression – Improvement (CGI-I) Scale scores.  

Top-line results showed that patients given SAGE-217 had an improvement of 17.8 points in the HAMD-17 score, compared to 13.6 for placebo. Sage Therapeutics added that after two weeks of treatment, remission was achieved in 45 percent of patients treated with SAGE-217, versus 23 percent in the placebo group.  The company further noted that at the end of the four-week follow-up, 53 percent of patients administered SAGE-217 achieved remission compared with 30 percent of patients who received placebo.

In addition, the MADRS score was significantly reduced in the SAGE-217 group versus placebo after two weeks of treatment, with this improvement maintained after four weeks, while significant improvements in patients receiving SAGE-217 were also noted for the HAM-A and CGI-I scores.  

Commenting on the news, Stifel analyst Paul Matteis described the data as an "outstanding outcome," adding that the "safety and tolerability profile looks clean." The analyst noted that the findings portend a good outcome for Sage's ongoing late-stage study of SAGE-217 in major depressive disorder. 

Matteis further stated that the absence of reports of loss of consciousness should reduce investor concerns associated with Zulresso (brexanolone). The FDA is expected to issue a decision regarding approval of the drug in March after extending (https://firstwordpharma.com/node/1605885?tsid=33) its review of the treatment by three months.  

The study results come after Sage revealed last June that it was proceeding with an expedited development programme for SAGE-217 in both PPD and MDD following a meeting with the FDA. Later in the year, the drugmaker inked a deal with Shionogi to jointly develop and market the drug in Japan, Taiwan and South Korea. 

For related analysis, see ViewPoints: Could Sage Therapeutics be biopharma's next acquisition target? 

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