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SAGE Therapeutics Initiates Phase 2a Trial of SAGE-547 in Postpartum Depression
"Postpartum depression is a serious medical condition that can have a devastating effect on the patient and her family. Therapeutic options for PPD are extremely limited, and there is a great need for new medicines to aid patients suffering with this disorder," said
This Phase 2a trial is an open-label study of SAGE-547 as an adjunctive therapy, or treatment given with current therapeutic approaches, in patients with severe PPD. This trial is expected to enroll at least 10 women with severe PPD who have experienced a major depressive episode within four weeks following delivery. This trial is designed to provide data regarding safety, tolerability and the acute effect of SAGE-547 on depressive symptoms as measured by the Hamilton Rating Scale for Depression (HAM-D) and Clinical Global Impression-Improvement Scale (CGI-I), respectively. Patients will be administered SAGE-547 intravenously for 48 hours and will be monitored for up to 30 days following treatment. The study is being conducted by
"SAGE-547 is a potent and selective modulator of GABAA, a receptor that plays a role in many CNS disorders but has been difficult to target effectively without considerable accompanying side effects," said
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 in Phase 1/2 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 Phase 2 clinical trials for the treatment of essential tremor and as an adjunctive therapy for the treatment of severe postpartum depression (PPD). In 2014, the
About Postpartum Depression
Postpartum Depression (PPD) is a major depressive disorder that occurs in approximately 15 to 20 percent of women who have recently given birth, with up to 10 percent classified as suffering from severe PPD1,2. PPD may have devastating consequences for a woman and for her family, including 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 current therapeutic options for severe PPD are limited.
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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 the potential safety, pharmacological effect and efficacy of SAGE-547 as a treatment for SRSE and PPD, the expected development pathway for SAGE-547 and its other product candidates and its expectations with respect to the timing and success of its clinical trials, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. 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 product 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 most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in SAGE's subsequent filings with the
1 Edge D. Ethnicity, psychosocial risk, and perinatal depression - a comparative study among inner-city women in the
2 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
3 Earls MF;
CONTACT: Media Contact:Source:Dan Budwick ,Pure Communications dan@purecommunicationsinc.com 973-271-6085 Investor Contact:Paul Cox ,SAGE Therapeutics paul.cox@sagerx.com 617-299-8377
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