Expected regulatory pathway for episodic
treatment of major depression remains unchanged with plan for one
new additional efficacy study
Pursuing two additional pathways with the goal
of accelerating patient access to zuranolone while continuing
development for the episodic treatment of depression
Plans to pursue novel development and filing
pathway for acute, rapid treatment of major depressive episodes
when co-initiated with new antidepressant with one additional
short-term pivotal study
Filing pathway for postpartum depression
anticipated to require one additional study without long-term
follow-up
Sage Therapeutics, Inc. (NASDAQ: SAGE), a biopharmaceutical
company committed to developing novel therapies with the potential
to transform the lives of people with debilitating disorders of the
brain, today announced next steps in the Landscape Program, the
clinical program evaluating zuranolone (SAGE-217) for the treatment
of postpartum depression (PPD) and major depressive disorder (MDD),
following a Breakthrough Therapy guidance meeting with the U.S.
Food and Drug Administration (FDA). Sage has identified three
potential pathways intended, if successful, to support a possible
filing for approval of zuranolone in the U.S. in two novel
indications – PPD and acute treatment of MDD when co-initiated with
a new antidepressant – along with the previously disclosed
development plan for the treatment of MDD as an episodic
therapy.
“Following FDA guidance, Sage has several potential pathways to
bring zuranolone to patients, if we are successful, with two
pathways that would represent unique indications that we believe we
can progress quickly and efficiently, while in tandem we pursue our
original approach to develop zuranolone for the episodic treatment
of depression,” said Jeff Jonas, M.D., chief executive officer of
Sage Therapeutics. “The development program for zuranolone is an
example of Sage’s ability to think differently about depression,
with the goal of providing treatment options that help people with
depression get better, sooner. Sage is well-positioned for the path
forward, and to continue advancing our multi-franchise
strategy.”
Zuranolone Landscape Program The Landscape Program is
evaluating the potential of zuranolone as a rapid-acting,
short-course oral treatment for PPD and MDD. It includes three
completed pivotal efficacy studies evaluating zuranolone 30 mg in
PPD (ROBIN Study) and MDD (MDD-201, MOUNTAIN Study), the results of
which have been previously reported.
Planned studies to support multiple filing pathways
Following discussions with the FDA, Sage plans to initiate three
new short-term clinical studies in 2020, with the potential, if
successful, for three distinct indications: PPD, acute rapid
response therapy in MDD when co-initiated with a new standard
antidepressant, and episodic treatment of MDD. These planned
studies include:
1. For use as an oral therapy in women
with PPD: one additional positive pivotal trial, along with
data from previously completed studies, is expected to be required
to support an efficacy claim in PPD. No additional long-term
follow-up is expected to be required to support an efficacy claim
in this indication:
- Placebo-controlled trial evaluating a two-week course of
zuranolone 50 mg in women with PPD, with additional short-term
follow-up. Topline data from this study is anticipated in
2021.
2. For use as an acute rapid response
therapy (RRT) in patients with MDD when co-initiated with new
standard antidepressant therapy: one additional positive
treatment study, along with data from previously completed acute
treatment studies, is expected to be required to support an
efficacy claim in this indication:
- Placebo-controlled trial evaluating a two-week course of
zuranolone 50 mg, when co-initiated with an open-label SSRI, in
patients with MDD, with additional short-term follow-up. Topline
data from this study is anticipated in 2021.
3. For use as an episodic therapy in
patients with MDD: one additional positive pivotal trial,
along with previously completed acute treatment studies and
long-term safety data, including data from REDWOOD (MDD-302), are
expected to be required to support an NDA filing for episodic
treatment of depression:
- Placebo-controlled trial evaluating a two-week course of
zuranolone 50 mg in patients with MDD, with additional short-term
follow-up. Topline data from this study is anticipated in
2021.
Updates to three ongoing or paused studies:
- SHORELINE Study (MDD-303): The
Company is on track to report topline data in 2020 from patients
with MDD who received zuranolone 30 mg in the SHORELINE Study.
- The protocol has been amended to allow currently enrolled
patients to receive retreatment with zuranolone 50 mg.
Additionally, the Company expects to enroll a new cohort of
patients with MDD who will receive zuranolone 50 mg.
- REDWOOD Study (MDD-302): The
Company paused enrollment in the REDWOOD study in the fourth
quarter of 2019 and plans to reevaluate timing for reinitiating the
study while resources and activities focus on enrollment in the
three new planned Phase 3 clinical studies.
- RAINFOREST Study (MDD-304): The
Company paused enrollment in the RAINFOREST study in the fourth
quarter of 2019. The Company plans to evaluate data from ongoing
and planned short-term studies prior to reinitiating
enrollment.
The updated development plan is expected to create flexibility,
if successful, to pursue an efficient and expedited pathway to
filing based on data from an additional positive efficacy study
(e.g. in MDD when co-initiated with a new antidepressant or in
PPD), which the Company believes can be achieved without further
long-term follow-up data.
The Company is also currently evaluating the ongoing zuranolone
clinical pharmacology and safety program and plans to finalize
requirements to support a potential future new drug application
(NDA) with the FDA.
Financial Guidance Based on its current operating plan
and assumptions with respect to future plans and resource
allocation decisions, Sage anticipates that its balance of cash,
cash equivalents, restricted cash, and marketable securities of
approximately $1.0 billion as of December 31, 2019, will support
operations into 2022. The Company is currently re-assessing its
resource allocation and prioritization strategy in light of the
development of zuranolone, the uptake of ZULRESSO™ (brexanolone)
CIV injection, and factoring in the potential impact on its
business of the unprecedented global public health crisis. The
Company plans to share its updated resource allocation strategy
during its first quarter earnings call.
About Zuranolone Zuranolone (SAGE-217) is a once-daily,
two-week therapy in development for the treatment of major
depressive disorder (MDD) and postpartum depression (PPD).
Zuranolone is an investigational oral neuroactive steroid (NAS)
GABAA receptor positive allosteric modulator (PAM). The GABA system
is the major inhibitory signaling pathway of the brain and central
nervous system and contributes significantly to regulating brain
function. Zuranolone has been granted Breakthrough Therapy
Designation by the U.S. Food & Drug Administration.
About Major Depressive Disorder Major depressive disorder
(MDD), commonly referred to as depression, is a brain health
disorder that affects an estimated 17 million adults in the U.S.
each year. It is one of the largest contributors to disability in
the U.S. and worldwide and is characterized by symptoms of
depressed mood and/or loss of interest in pleasurable activities.
MDD causes significant impairment in daily life and can limit a
person’s ability to fulfill work, school, family, or social
responsibilities; enjoy leisure activities; or maintain health and
hygiene. While antidepressants are widely used to treat MDD,
large-scale studies have demonstrated that there is an unmet need
in the treatment of MDD, including during the weeks between
initiation of treatment and onset of effect, as well as the need
for new therapeutic options.
About Postpartum Depression Postpartum depression (PPD)
is one of the most common medical complications during and after
pregnancy. PPD can have a serious negative impact on a woman,
including 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. PPD is estimated to affect approximately one in nine
women who have given birth in the U.S. or approximately 400,000
women annually.
About Sage Therapeutics Sage Therapeutics is a
biopharmaceutical company committed to developing novel therapies
with the potential to transform the lives of people with
debilitating disorders of the brain. We are pursuing new pathways
with the goal of improving brain health, and our depression,
neurology and neuropsychiatry franchise programs aim to change how
brain disorders are thought about and treated. Our mission is to
make medicines that matter so people can get better, sooner. 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 various
potential development and regulatory pathways for zuranolone in MDD
and PPD; our expectations as to the timing of initiation of
clinical trials and reporting of results; our expectations
regarding the potential sufficiency of the planned development
program, if successful, to support regulatory filings and approvals
of zuranolone in MDD and PPD; our estimates as to the number of
patients with MDD and PPD; our statements regarding the potential
for efficient and expedited development of zuranolone and being
well-positioned for the path forward; the potential profile and
benefit of zuranolone and our other product candidates; our
expectations with respect to use of cash based on the current
operating plan and assumptions as to future decisions and plans;
and the goals, opportunity and potential for our business. 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 encounter delays in initiation or conduct of our planned
clinical trials, including slower than expected site initiation or
enrollment, that may impact our ability to meet our expected
time-lines; we may not be successful in our development of
zuranolone in MDD or PPD or in our development of any of our other
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, and ongoing and future non-clinical and
clinical results may not meet their primary or key secondary
endpoints or be sufficient to file for or gain regulatory approval
to market the product without further development work or may not
support further development at all; we may encounter adverse events
at any stage of development that negatively impact further
development or that require additional nonclinical and clinical
work which may not yield positive results; we may encounter
different or more severe adverse events at the higher doses we are
planning to study in new trials; we may encounter issues with the
efficacy or durability of short-term treatment, or co-initiated
treatment or safety and efficacy concerns with respect to
retreatment that require additional studies be conducted; the FDA
may ultimately decide that the design or results of our completed
and planned clinical trials for zuranolone, even if positive, are
not sufficient for regulatory approval in the indications that are
the focus of our development plan; other decisions or actions of
the FDA or other regulatory agencies may affect the initiation,
timing, design, size, progress and cost of clinical trials and our
ability to proceed with further development; the actual size of the
MDD and PPD patient populations may be significantly lower than our
estimates and, even if zuranolone is approved, it will only be
approved or used to treat a subset of the relevant patient
populations; the spread of the coronavirus and related fears in the
U.S. and outside the U.S., measures taken to curb the spread of the
virus, and avoidance of healthcare settings and public interactions
as a result of the foregoing may impact expected site initiation or
enrollment in our clinical trials and our ability to meet our
expected time-lines or may significantly impact other aspects of
our business causing us to have to change our plans; we may
encounter technical and other unexpected hurdles in the development
and manufacture of zuranolone or any of our other products which
may delay our timing or change our plans; the internal and external
costs required for our ongoing and planned activities, and the
resulting impact on expense and use of cash, may be higher than
expected which may cause us to change or curtail some of our plans;
and our expectations as to cash usage and cash needs may prove not
to be correct for other reasons such as changes in plans or actual
events being different than our assumptions; as well as those risks
more fully discussed in the section entitled "Risk Factors" in our
most recent Annual Report on Form 10-K, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200318005176/en/
Investor Contact Jeff Boyle 617-949-4256
jeff.boyle@sagerx.com
Media Contact Alexis Smith 617-588-3740
alexis.smith@sagerx.com
Sage Therapeutics (NASDAQ:SAGE)
Historical Stock Chart
From Feb 2024 to Mar 2024
Sage Therapeutics (NASDAQ:SAGE)
Historical Stock Chart
From Mar 2023 to Mar 2024