First time detailed data for SAGE-547 in postpartum depression (PPD) to be presented
PPD data includes secondary endpoints and timeline of response
SAGE-718 pre-clinical data unveiled in late-breaker
First time data from Sage’s NMDA modulator platform to be presented
CAMBRIDGE, Mass., March 28, 2016 (GLOBE NEWSWIRE) -- Sage Therapeutics (NASDAQ:SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced two upcoming poster presentations at the Society of Biological Psychiatry 71st Annual Scientific Meeting, taking place May 12-14, 2016 in Atlanta, GA.
“For a condition such as PPD, where the treatment options are limited and there are serious health implications for mother and child, the dramatic and sustained reduction in the Hamilton Rating Scale for Depression (HAMD) throughout the treatment period in our four trial participants is highly encouraging. For the first time, we will share detailed data from our previous open-label, proof-of-concept study for SAGE-547 in PPD, including secondary endpoints,” said Steve Kanes, M.D., Ph.D., Chief Medical Officer of Sage. “Additionally, the promising preclinical data from our first NMDA positive allosteric modulator candidate, SAGE-718, highlights our expanding development pipeline that focuses on CNS disorders characterized by NMDA hypofunction.”
SAGE-547 was well-tolerated in the open-label, proof-of-concept study with no serious adverse events reported during the treatment and follow-up periods and no discontinuations due to adverse events. The only adverse event reported in more than one patient was sedation, observed in two patients.
The schedule for the presentations is as follows:
Date: Thursday, May 12, 2016
Presentation Time: 5:00 p.m. – 7:00 PM (ET)
Location: Hyatt Regency Atlanta, Grand Hall West - LL2, Atrium Tower
Title: The Open-label, Proof-of-concept Study of SAGE-547 (Allopregnanolone) in the Treatment of Postpartum Depression (link to abstract)
Date: Friday, May 13, 2016
Presentation Time: 5:00 p.m. – 7:00 PM (ET)
Location: Hyatt Regency Atlanta, Grand Hall West - LL2, Atrium Tower
Title: Development and Characterization of an NMDA Positive Allosteric Modulator with Effects in Pre-Clinical Models of Psychosis and Cerebrosterol Deficit Disorders (link to abstract)
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 and SAGE-689, 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 concerning SAGE's future expectations, plans and prospects constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995, including without limitation, statements as to the potential for SAGE’s product candidates in the treatment of postpartum depression and other 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: success in SAGE's pre-clinical studies or in early stage clinical trials may not be repeated or observed in ongoing or future studies involving the same compound or other product candidates; future pre-clinical and clinical results may not support further development of product candidates; SAGE may not be able to successfully demonstrate the efficacy and safety of its product candidates at each stage of development; decisions or actions of regulatory agencies may affect the initiation, timing, progress and cost of clinical trials, and SAGE's ability to proceed with further clinical studies of a product candidate or to obtain marketing approval; and SAGE may encounter technical and other unexpected hurdles in the manufacture and development of its products, as well as those risks more fully discussed in the section entitled "Risk Factors" in SAGE's most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in SAGE's subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent SAGE's views only as of today and should not be relied upon as representing its views as of any subsequent date. SAGE explicitly disclaims any obligation to update any forward-looking statements.