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Sage Announces Expedited Development Plan for SAGE-547 in the Treatment of Postpartum Depression based on FDA Breakthrough Therapy Meeting
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
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
"We are encouraged by the FDA's feedback and appreciate their guidance
regarding our SAGE-547 development program in postpartum depression,"
said
As confirmed by the
-
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
About FDA Breakthrough Therapy Designation
The
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
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
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
1 Hamilton BE, Martin JA, Osterman MJK, et al. Births: Final
data for 2014. National Vital Statistics Reports.
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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Investors:
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or
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