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 FDA for treatment of postpartum depression; near-term
meeting with FDA planned to discuss development pathway
Sage Therapeutics (NASDAQ:SAGE), a clinical-stage
biopharmaceutical company developing novel medicines to treat
life-altering central nervous system disorders, today announced
positive results on secondary endpoints from its Phase 2 clinical
trial of SAGE-547 for the treatment of severe postpartum depression
(PPD) at The Marcé Society for Perinatal Mental Health held
September 26 – 28, 2016 in Melbourne, Australia. Secondary
endpoints in the study, including the Edinburgh Perinatal
Depression Scale (EPDS) and the Patient Health Questionnaire
(PHQ-9) showed improvement through 30 days in the SAGE-547-treated
group compared to the placebo group, demonstrating a strong
durability of effect from SAGE-547 for over three weeks following
the end of treatment. These data are consistent with previously
reported top-line results showing SAGE-547 achieved the primary
endpoint with a statistically significant reduction in the Hamilton
Rating Scale for Depression (HAM-D) compared to placebo at 60 hours
and maintained at similar magnitude through the 30-day follow-up. A
similar statistically significant response was observed on other
secondary endpoints including the Montgomery-Åsberg Depression
Rating Scale (MADRS) and Remission from depression, as determined
by a HAM-D of less than 7. The company is pursuing publication of a
comprehensive dataset from the Phase 2 trial in severe PPD in a
peer-reviewed journal. The U.S. Food and Drug Administration (FDA)
granted Breakthrough Therapy Designation to SAGE-547 for the
treatment of postpartum depression (PPD). There are no approved
therapies specifically for PPD.
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 July
2016. SAGE-547 was found to be generally well-tolerated with no
serious adverse events reported during the treatment and follow-up
periods. A greater number of adverse events were reported in the
placebo arm than in the treatment arm of the trial (4 of 10 on
SAGE-547 and 8 of 11 on placebo). Similar number of patients
reported Nervous System Disorder Adverse Events: 3 of 10 on
SAGE-547 and 4 of 11 on placebo. Equal number of patients reported
the cluster of dizziness, sedation or somnolence: 3 in each group.
Fewer SAGE-547 patients reported Psychiatric Disorder Adverse
Events: 0 of 10 on SAGE-547 and 5 of 11 on placebo.
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 U.S. each year.
The unmet need for treatment in this vulnerable patient is
significant. PPD carries an increased risk for suicide and it is
one of the strongest predictors of suicidal ideation in new
mothers,” said Steve Kanes, M.D., Ph.D., Chief Medical Officer of
Sage. “The results of the secondary endpoints in this Phase 2 study
of SAGE-547, including the Edinburgh Perinatal Depression Scale and
PHQ-9, support the primary endpoints achieved in the trial. Data
from this clinical program show improvement in the SAGE-547 group
compared with placebo and the secondary endpoints are suggestive of
improvement through 30 days in the SAGE-547 treatment group. These
collective findings have the potential to create a paradigm shift
in how PPD is thought about and – if our program is successful –
how PPD might be treated in the future.”
The U.S. Food and Drug Administration (FDA) recently granted
Breakthrough Therapy Designation to SAGE-547 for the treatment of
PPD. Breakthrough Therapy Designation is intended to expedite the
development and review of a drug candidate that is planned for use
to treat a serious or life-threatening disease or condition when
preliminary clinical evidence indicates that the drug may
demonstrate substantial improvement over existing therapies on one
or more clinically significant endpoints. In the near term, Sage
plans to meet with the FDA to discuss the development pathway for
SAGE-547 in PPD.
About the Marcé Society for Perinatal Mental Health
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 FDA for the treatment of
postpartum depression (PPD). SAGE-547 is an intravenous agent
evaluated in the PPD-202A trial, a multi-center, randomized,
double-blind, parallel-group, placebo-controlled study evaluating
the efficacy, safety and pharmacokinetics of SAGE-547 in the
treatment of adult female patients with severe PPD. Following
top-line results in July 2016, Sage initiated an expansion of the
Phase 2 clinical program of SAGE-547 in PPD with two randomized,
placebo-controlled Phase 2 clinical trials to explore dose-ranging
of SAGE-547 in severe PPD patients and to evaluate SAGE-547
efficacy in moderate PPD patients. For more information about
participating in these trials, please contact
clinicaltrials@sagerx.com.
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 FDA for the
treatment of SRSE.
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, and is being
developed for postpartum depression. Sage is developing its next
generation modulators, including SAGE-217, SAGE-689 and SAGE-718,
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 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160927005878/en/
Sage TherapeuticsInvestors:Paul Cox,
617-299-8377paul.cox@sagerx.comorMedia:Suda Communications
LLCMaureen L. Suda, 585-387-9248maureen.suda@sagerx.com
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