Investors & Media
News
Sage Reports Additional Positive Data on Secondary Endpoints from Phase 2 Clinical Trial of SAGE-547 in Severe Postpartum Depression at the Marcé Society for Perinatal Mental Health Biennial Scientific Meeting
Secondary endpoints showed significant difference in improvement from baseline for SAGE-547 compared to placebo over three weeks following end of treatment
Data are consistent with previously reported top-line results, including primary endpoint achieved with statistical significance at 60 hours and maintained through 30 days
Pursuing publication of comprehensive dataset in a peer-reviewed journal
Currently dosing patients with moderate or severe PPD in separate placebo-controlled trials; top-line data expected in 2017
Breakthrough Therapy Designation recently granted by
Data from the EPDS showed a mean change from baseline at 30 days in the EPDS total score for the SAGE-547 group of -13.5 compared with a mean change from baseline of -5.3 in the placebo group, which was a statistically significant difference (p=0.024). The EPDS is a patient-rated depressive symptom severity scale specific to the perinatal period. Data from PHQ-9 showed that at day 30, six patients (60%) in the SAGE-547 group compared to one patient in the placebo group had a score of 0 to 4 indicating minimal or no depression (p=0.024). The PHQ-9 is a self-administered rating scale which is used to measure severity of symptoms and response to treatment. Items cover the core major depression symptoms.
The secondary endpoints were measured as part of a Phase 2,
multi-center, placebo-controlled, double-blind, 1:1 randomization trial
that was designed to enroll up to 32 women. The population studied were
21 women with severe PPD (HAM-D ≥26) who developed severe depression
either in the third trimester or within four weeks of childbirth. At
baseline, the mean HAM-D scores for both the SAGE-547-treated group and
the placebo group were greater than 28. The primary objective of the
trial was to evaluate the effect of SAGE-547 on depression as measured
by the HAM-D score, compared to placebo, at 60 hours. In addition,
patients were monitored during a 30-day follow-up period to assess both
safety and efficacy. Top-line results from the trial were announced in
Based on the positive results from the Phase 2 clinical trial in severe PPD, Sage has expanded its development program evaluating SAGE-547 for PPD with the initiation of two additional multi-center, placebo-controlled trials, one of which is a dose-ranging study of SAGE-547 in severe PPD patients and the other of which is studying the efficacy of SAGE-547 in moderate PPD patients. Top-line results from these two trials are expected in 2017.
"Postpartum depression represents a severely understudied and
under-diagnosed class of patients. PPD is currently estimated to affect
between 500,000 and 750,000 mothers in the
The
About the Marcé
The principal aim of the Marcé Society is to promote, facilitate and communicate about research into all aspects of the mental health of women, their infants and partners around the time of childbirth. This involves a broad range of research activities ranging from basic science through to health services research.
About Postpartum Depression
Postpartum depression (PPD) is an affective disorder impacting women after childbirth. PPD may have devastating consequences for a woman and for her family, which may include significant functional impairment, 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 and poor self-esteem. Suicide is the leading cause of maternal death following childbirth. It is estimated that PPD affects 500,000 to 750,000 mothers in the US each year 1,2. A subset of these are severe enough to require hospitalization. There are no approved therapies for PPD and there is a high unmet medical need for improved pharmacological therapy in PPD.
About SAGE-547
SAGE-547 is an allosteric modulator of both synaptic and extra-synaptic
GABAA receptors. SAGE-547 has been granted Breakthrough Therapy
Designation by the
SAGE-547 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.
SAGE-547 has been granted both Fast Track and orphan drug designations
by the
About
Forward-Looking Statements
Various statements in this release concern Sage's future expectations, plans and prospects, including without limitation: our plans with respect to additional clinical trials of SAGE-547 in the treatment of PPD and the potential timing of data from these trials; our views as to the unmet need for additional treatment options in PPD and the estimated number of patients with PPD; our statements as to the potential for expedited development and review for SAGE-547 in PPD as a result of the breakthrough therapy designation; and our other statements regarding the potential of Sage's 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 achieve expedited development or review of SAGE-547 as a result of the breakthrough therapy designation; decisions or actions of the FDA or other regulatory agencies may affect the initiation, timing, design, size, and progress of clinical trials, and our ability to proceed with further clinical studies of SAGE-547 in PPD or to obtain marketing approval; we may not be able to successfully demonstrate the efficacy and safety of our product candidates at each stage of development; success in early stage clinical trials 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 may not support further development of a product candidate or be sufficient to gain regulatory approval to market any product; we may decide that a development pathway for one of our product candidates in one or more indications is no longer feasible or advisable; the number of patients with a particular disease or the unmet need for additional treatment options in a disease 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160927005878/en/
Investors:
paul.cox@sagerx.com
or
Media:
maureen.suda@sagerx.com
Source:
News Provided by Acquire Media