Current SAGE-547 clinical program is designed
to support potential NDA submission; no additional controlled
studies anticipated
The current trials will be expanded to Phase 3
trials to facilitate potential for global registration
If successfully developed, SAGE-547 has the
potential to be the first FDA-approved treatment for postpartum
depression
Sage Therapeutics (NASDAQ:SAGE), a clinical-stage
biopharmaceutical company developing novel medicines to treat
life-altering central nervous system (CNS) disorders, today
announced its expedited development plan for SAGE-547 following
receipt of formal meeting minutes from a breakthrough therapy
meeting with the U.S. Food and Drug Administration (FDA). This
program is intended to support a potential filing for approval in
the treatment of postpartum depression (PPD).
The current SAGE-547 program in PPD, along with prior Phase 2
data, were confirmed as supporting, if successful, a potential New
Drug Application (NDA). Sage’s PPD clinical program, now in Phase
3, will require only minor modifications, including an increase in
sample size. Agreement with the FDA was achieved on the clinical
endpoints for these pivotal trials. Sage anticipates announcing
top-line data from the PPD registration trials in 2H 2017. In July
2016, Sage reported encouraging top-line results from the 202A
placebo-controlled trial in women with severe PPD, in which
SAGE-547 achieved a significant, rapid and durable reduction (at
Day 30) in depression scores compared with placebo.
“We are encouraged by the FDA’s feedback and appreciate their
guidance regarding our SAGE-547 development program in postpartum
depression,” said Jeff Jonas, M.D., Chief Executive Officer of
Sage. “Based on our meeting, we have clear and efficient direction
for the expedited development path forward for SAGE-547 to
potentially support a New Drug Application (NDA) in 2018.”
As confirmed by the FDA, the following are the elements of the
expected clinical and regulatory path moving forward:
- Agreement and clarity was achieved with
the FDA on an expedited path forward
- Current SAGE-547 clinical studies
confirmed as appropriate to support registration, if
successful
- No additional efficacy studies
expected to be required beyond those currently underway
- Trial design of studies 202B and 202C
are considered appropriate for registration, with increase in size
and other minor modifications
- The primary clinical endpoint for these
pivotal trials was unchanged and agreed upon with FDA
- Additional patient safety data may be
acquired through an open-label program
Sage received Breakthrough Therapy Designation from the FDA for
SAGE-547 in PPD in September, 2016. The Breakthrough Therapy
Designation is intended to offer a potentially expedited
development path and review for promising drug candidates, which
includes increased interaction and guidance from the FDA. Sage
achieved this regulatory designation based primarily on the
positive results from the placebo-controlled 202A study of SAGE-547
in 21 patients with severe PPD. The trial met the primary endpoint
of significant reduction in the Hamilton Rating Scale for
Depression (HAM-D) score in the SAGE-547-treated group compared
with placebo at 60 hours, with an effect that was maintained at
similar magnitude through the 30-day follow-up period. SAGE-547 was
generally well tolerated in the study. There were no deaths,
serious adverse events or discontinuations due to adverse
events.
About FDA Breakthrough Therapy Designation
The FDA's Breakthrough Therapy Designation is intended to
expedite the development and review of a drug candidate that is
planned for use, alone or in combination with one or more other
drugs, 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. The benefits of
Breakthrough Therapy Designation include the same benefits as Fast
Track Designation, plus an organizational commitment involving
FDA’s senior managers with more intensive guidance from the FDA.
Breakthrough Therapy Designation does not change the standards for
approval.
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 year1,2. 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
clinical program of SAGE-547 in PPD with two randomized,
placebo-controlled Phase 3 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
compound, SAGE-547, is in Phase 3 clinical development for
super-refractory status epilepticus, a rare and severe seizure
disorder, and for postpartum depression. Sage is developing its
next generation modulators, including SAGE-217 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 statements as to the potential for expedited development and
review for SAGE-547 in PPD; our expectations as to the timing of
results from our pivotal clinical trials in PPD; the potential for
a future regulatory filing for approval of SAGE-547 in PPD, and our
expectations for the potential timing of such a filing; the
potential for approval of SAGE-547 in PPD; our estimates as to the
number of patients with PPD; and our 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; despite the results
of the breakthrough therapy meeting, the FDA may ultimately decide
that the design or results of our clinical trials are not
sufficient for regulatory approval; decisions or actions of
the FDA or other regulatory agencies may affect the
timing, design, size, progress and cost of our clinical trials, and
our ability to proceed with further clinical studies of SAGE-547 in
PPD or to obtain marketing approval; we may encounter delays in
enrollment and site initiation that may impact our ability to meet
our expected time-lines; we may not be successful in our
development of SAGE-547 in PPD or in our development of any of our
product candidates in any indication we are currently pursuing or
may in the future pursue; success in our non-clinical studies or in
earlier 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 pre-clinical and
clinical results may not support further development of product
candidates or be sufficient to gain regulatory approval to market
any product; we may encounter adverse events at any stage of
development that negatively impact further development; the actual
size of the PPD patient population may be significantly lower than
our estimates and, even if SAGE-547 is approved for PPD, only a
subset of the PPD population will be considered for treatment with
a drug delivered through IV administration; and we may encounter
technical and other unexpected hurdles in the development and
manufacture of our products which may delay our timing or change
our plans, 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/20161206005520/en/
Investors:Sage TherapeuticsPaul Cox,
617-299-8377paul.cox@sagerx.comorMedia:Suda Communications
LLCMaureen L. Suda, 585-387-9248maureen.suda@sagerx.com
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