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SAGE Therapeutics Announces Positive Top-Line Data in Exploratory Trial of SAGE-547 in Postpartum Depression
Marked Improvement Demonstrated in HAM-D Scores in Patients with PPD Enrolled in Open-Label Trial
Plan to Initiate Placebo-Controlled Trial of SAGE-547 by Year End and Advance Novel Product Candidates for
"Severe postpartum depression is a serious and debilitating form of major depressive disorder," said
PPD is estimated to affect up to 20% of women following childbirth. The HAM-D scale is used by clinicians to rate the severity of 17 symptoms observed in depression, such as low mood, insomnia, agitation, anxiety and weight loss. A HAM-D rating of greater than 24.0 is considered severe and a score below 7.0 is considered symptom-free.
"These top-line results demonstrate an early but encouraging signal of activity in women with severe PPD and we believe further validate that the SAGE-547 mechanism of action has the potential to impact a broad range of disorders beyond epilepsy," said
The exploratory open-label trial recruited women with PPD for treatment with a proprietary dosing schedule of SAGE-547 as an adjunctive therapy, a therapy combined with current therapeutic approaches. The trial was designed to provide data regarding safety, tolerability, pharmacokinetics and the acute effect of SAGE-547 on depressive symptoms as measured by the HAM-D and CGI-I. All of the patients enrolled had a Major Depressive Episode, as diagnosed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) and were treated as inpatients. All four patients had an inadequate response to prior antidepressant therapy. The initial trial planned to enroll up to 15 patients or until 10 patients were deemed to be evaluable, whichever occurred first, aged 18 to 45 years, but after the consistent responses observed, the initial findings justified accelerating the program into a placebo-controlled trial.
SAGE-547 was well-tolerated with no serious adverse events reported during the treatment and follow-up periods and no discontinuations due to adverse events. A total of 14 adverse events were reported in four patients. The only adverse event reported in more than one patient was sedation, observed in two patients.
"I would like to thank these patients for participating in the trial and the nurses, physicians and staff at the Perinatal Psychiatry Inpatient Unit at
About SAGE-547
SAGE-547 is an allosteric modulator of both synaptic and extra-synaptic GABAA receptors. GABAA receptors are widely regarded as validated drug targets for a variety of disorders, with decades of research and multiple approved drugs targeting these receptor systems. SAGE-547 is an intravenous agent entering Phase 3 clinical development as an adjunctive therapy, a therapy combined with current therapeutic approaches, for the treatment of super-refractory status epilepticus (SRSE), as well as in exploratory development for the treatment of essential tremor and postpartum depression. SAGE plans to begin enrollment of its planned Phase 3 clinical trial, called the STATUS Trial, in mid-2015. SAGE-547 has been granted both Fast Track and orphan drug designations by the
About Postpartum Depression
Postpartum Depression (PPD) is distinct and readily identified form of depressive disorder estimated to affect up to 20% of women following childbirth1,2. PPD may have devastating consequences for a woman and for her family, which may include depressed mood and/or loss of interest in her newborn, and associated symptoms of depression such as loss of appetite, difficulty sleeping, motor challenges, lack of concentration, loss of energy, poor self-esteem and suicidality. PPD is reported to be the most under-diagnosed obstetric complication in the U.S.3 and there is a continued need for improved pharmacological therapy for PPD.
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Forward-Looking Statements
Various statements in this release concerning SAGE's future expectations, plans and prospects, including without limitation, SAGE's expectations regarding SAGE-547 as a treatment for SRSE, essential tremor and severe postpartum depression, statements concerning the potential safety and efficacy of SAGE-547 and durability of response, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. In addition, it should be noted that there is limited data concerning the safety and efficacy of SAGE-547. These data may not be repeated or observed in ongoing or future studies involving SAGE-547 or SAGE's other product candidates. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, SAGE's ability
to successfully demonstrate the efficacy and safety of its drug candidates, the pre-clinical and clinical results for its product candidates, which may not support further development of product candidates, actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials, obtaining, maintaining and protecting intellectual property, SAGE's ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties, competition from others developing products for similar uses, SAGE's ability to manage operating expenses, SAGE's ability to obtain additional funding to support its business activities and establish and maintain strategic business alliances and new business initiatives, SAGE's dependence on third parties for development, manufacture, marketing, sales and distribution of products, the outcome of
litigation, and unexpected expenditures, as well as those risks more fully discussed in the section entitled "Risk Factors" in SAGE's annual report on Form 10-K for the fiscal year ended
1 O'Hara MW, Wisner KL. Perinatal mental illness: definition, description and aetiology. Best Pract Res Clin Obstet Gynaecol 2014;28(1):3-12. doi: 10.1016/j.bpobgyn.2013.09.002
2 Gavin NI, Gaynes BN. Perinatal Depression A Systematic Review of Prevalence and Incidence. Obstetrics & Gynecology 12/2005; 106(5 Pt 1):1071-83. doi: 10.1097/01.AOG.0000183597.31630.db
3 Earls MF;
CONTACT: Investor Contact:Source:Paul Cox ,SAGE Therapeutics paul.cox@sagerx.com 617-299-8377 Media Contact:Dan Budwick ,Pure Communications dan@purecommunicationsinc.com 973-271-6085
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