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Sage Therapeutics Announces The Lancet Publishes Positive Phase 2 Brexanolone (SAGE-547) Clinical Data in Severe Postpartum DepressionSage Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced that The Lancet has published (online) results from a Phase 2, double-blind, randomized and placebo-controlled study of brexanolone (SAGE-547) in women with severe postpartum depression (PPD). The study found that treatment with brexanolone resulted in a clinically meaningful and statistically significant mean reduction in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score, a common measure of depression severity, that began at 24 hours and was maintained at similar magnitude until the 30-day follow-up. Brexanolone was well-tolerated in this study with no observations of deaths, serious adverse events or discontinuations. "There is a significant unmet need for new treatment options in PPD, for mothers suffering from the disorder, as well as their children and families. Currently available pharmacologic treatment options for PPD do not target the underlying mechanism or biology," said Samantha Meltzer-Brody, M.D., M.P.H., Associate Professor and Director of the UNC Perinatal Psychiatry Program of the UNC Center for Women's Mood Disorders and primary investigator of the study. "The rapid onset of action and duration of effect observed in this study compared to placebo suggest that brexanolone has the potential to address unmet needs in the treatment of patients suffering from PPD. If successfully developed and approved, this would be an enormous step forward for the field." "Postpartum depression is a common, biological complication of childbirth. It is a serious mood disorder associated with a range of debilitating symptoms that impact a women's ability to function, and is a leading cause of maternal suicide," said Steve Kanes, M.D.,Ph.D., Chief Medical Officer of Sage and lead author of the paper. "The publication of these data in The Lancet highlights the potential for brexanolone to be a treatment option for PPD. We are hopeful these findings will aid in the understanding of this disorder and the development of effective therapies." The study's primary efficacy endpoint was the mean change from baseline in the 17-item HAM-D total score in subjects who received brexanolone compared with subjects who received placebo at the 60-hour time point. As previously reported, at the end of the 60-hour infusion, brexanolone-treated subjects demonstrated a mean reduction in HAM-D total score of 20.97 points, a 12.2-point difference [95 %CI, -3.67 to -20.77] from placebo (p=0.008). The effect was statistically significant from 24 hours after initiation of treatment (-19.37 vs -8.12, p=0.006) until the 30-day follow-up (-20.77 vs -8.84, p=0.010). No deaths, serious adverse events or discontinuations were observed. Overall, fewer patients who received brexanolone experienced adverse events compared with placebo (4 of 10 on brexanolone and 8 of 11 on placebo). The most commonly reported adverse events in the trial were dizziness (2 brexanolone-treated subjects; 3 placebo-treated subjects) and somnolence (2 brexanolone-treated subjects; 0 placebo-treated subjects) and an equal number of patients reported the cluster of dizziness, sedation or somnolence (3 in brexanolone group and 3 in the placebo group).
PPD-202A Study Design and Additional Highlights Prespecified scondary endpoints of the study were assessed using validated and clinically relevant rating and diagnostic scales to evaluate severity of depression and to serve as a guide to evaluate recovery from baseline at 2 hours through 30 days. The outcomes were consistent with the primary endpoint results and included significant findings in measures assessed with the HAM-D, CGI (News - Alert) (Clinical Global Impression Scale), and MADRS (Montgomery-Åsberg Depression Rating Scale) scales.
About Postpartum Depression
About the Hamilton Rating Scale for Depression (HAM-D)
About Brexanolone (SAGE-547) Brexanolone is also being developed as an adjunctive therapy for the treatment of super-refractory status epilepticus (SRSE) in the global Phase 3 STATUS Trial. For more information about the STATUS Trial, please visit www.statustrial.com. Brexanolone has been granted both Fast Track and orphan drug designations by the FDA for the treatment of SRSE.
About Sage Therapeutics Forward-Looking Statements Various statements in this release concern Sage's future expectations, plans and prospects, including without limitation: our expectations regarding the potential for brexanolone in the treatment of PPD; our view as to the unmet need for additional treatment options in PPD and how brexanolone might address the needs of PPD patients and families, if successfully developed and approved; our estimate as to the number of patients with PPD; and our plans and expectations with respect to development of brexanolone and our other product candidates. 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 not be able to successfully demonstrate the efficacy and safety of brexanolone or any of our other product candidates at each stage of development; success in early stage clinical trials may not be repeated or observed in ongoing or future studies of brexanolone; the efficacy data generated in ongoing or future clinical trials may be less robust or we may encounter unexpected safety or tolerability issues; ongoing or future clinical trials may not support further development of brexanolone or our other product candidates or be sufficient to gain regulatory approval to market any product; decisions or actions of regulatory agencies may affect the initiation, timing, progress, number, size and cost of clinical trials, and our ability to proceed with further clinical trials of a product candidate in a particular indication, or at all, or our ability to obtain marketing approval; we may decide that a development pathway for a product candidate in one or more indications is no longer feasible or advisable or that the unmet need no longer exists; the number of patients with PPD or the unmet need for additional treatment options may be significantly smaller than we expect; 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. 1 Hamilton BE, Martin JA, Osterman MJK, et al. Births: Final data for 2014. National Vital Statistics Reports. National Center for Health Statistics, 2015, 64, 12. Available at http://www.cdc.gov/nchs/data/nvsr/nvsr64/nvsr64_12.pdf. 2 O'Hara MW, McCabe JE. Postpartum depression: Current status and future directions. The Annual Review of Clinical Psychology, 2013, 9, 379-407. doi: 10.1146/annurev-clinpsy-050212-185612.
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