SAGE Therapeutics Announces Completion Of Enrollment For Phase 2 Proof-Of-Concept Trial Of SAGE-547 In Severe Postpartum Depression

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sage Therapeutics, Inc. (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced that enrollment has been completed in its Phase 2 placebo-controlled, proof-of-concept clinical trial of SAGE-547 in women with severe postpartum depression (PPD).

The Company has decided to include 30-day follow-up data in its anticipated announcement of top-line data, and currently expects to report these results in July 2016. Presentation of a more comprehensive dataset from the trial is expected at a future medical meeting.

The Phase 2, proof-of-concept, multi-center, placebo-controlled, double-blind, 1:1 randomization trial is designed to enroll up to 32 female patients diagnosed with severe PPD, characterized by a Hamilton Rating Scale for Depression (HAM-D) score of =26 prior to treatment and less than 6 months postpartum. The primary endpoint of the study is the effect of SAGE-547 on the HAM-D score as measured by the change from baseline compared to placebo at 60 hours. Patients are being monitored during a 30-day follow-up period to assess both safety and behavioral outcomes.

About Sage Therapeutics
Sage Therapeutics is a clinical-stage biopharmaceutical company committed to developing novel medicines to transform the lives of patients with life-altering central nervous system (CNS) disorders. Sage has a portfolio of novel product candidates targeting critical CNS receptor systems, GABA and NMDA. Sage's lead program, SAGE-547, is in Phase 3 clinical development for super-refractory status epilepticus, a rare and severe seizure disorder. Sage is developing its next generation modulators, including SAGE-217, SAGE-689 and SAGE-718, with a focus on acute and chronic CNS disorders. For more information, please visit www.sagerx.com.

Forward-Looking Statements

Various statements in this release concern Sage's future expectations, plans and prospects, including without limitation, our expectations regarding the anticipated availability and announcement of data and results from the Phase 2 clinical trial; and our expectations regarding development of our product candidates and their potential in the treatment of various CNS disorders. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: we may experience delays in our analysis or reporting of data, including if we encounter the need for re-analysis or additional steps in the data analysis process; success in our early stage clinical trials or in non-clinical studies may not be repeated or observed in ongoing or future studies involving the same compound or other product candidates, and ongoing and future clinical results, including the results of the Phase 2 study, may not support further development of product candidates; regulatory agencies may not agree with our view of clinical data and other decisions or actions of regulatory agencies may affect the initiation, timing, progress and cost of clinical trials, and our ability to proceed with further clinical studies of a product candidate; and we may encounter technical and other unexpected hurdles in the development and manufacture of our product candidates, as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today, and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.