Zuranolone is being evaluated as a short
course, rapid-acting, oral medication for major depressive disorder
(MDD) and postpartum depression (PPD)
Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq:
BIIB) announced the completion of the rolling submission of a New
Drug Application (NDA) to the U.S. Food and Drug Administration
(FDA) for zuranolone in the treatment of major depressive disorder
(MDD) and postpartum depression (PPD). Zuranolone is an
investigational drug being evaluated as a rapid-acting, once-daily,
14-day oral short course treatment in adults with MDD and PPD. The
submission completes the NDA filing that was initiated earlier this
year.
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In the clinical development program to date, zuranolone showed
rapid and sustained improvement of depressive symptoms with a
generally well-tolerated and consistent safety profile. Zuranolone,
a neuroactive steroid, has a novel mechanism of action as a
positive allosteric modulator of GABA-A receptors. In people with
depression, it may help to rapidly rebalance dysregulated neuronal
networks to help restore brain function. Zuranolone targets brain
networks responsible for functions such as mood, arousal, behavior,
and cognition.
“Based on the data in the LANDSCAPE and NEST programs, we
believe that zuranolone has the potential to be a meaningful new
therapy for depression,” said Priya Singhal, M.D., M.P.H., Head of
Global Safety and Regulatory Sciences and Interim Head of R&D
at Biogen. “We look forward to working with the FDA as this filing
progresses.”
“Mental health is a highly underserved area with an urgent unmet
need for innovative therapies. We need to rethink how MDD and PPD
are treated. Existing treatments often take weeks to months to
provide symptom relief, and patients may need to cycle through
multiple treatment options to fully address their symptoms. People
with MDD and PPD deserve better,” said Laura Gault, M.D., Ph.D.,
Chief Medical Officer at Sage. “We believe that zuranolone, if
approved, could evolve the way depression is treated and this
submission brings us one step closer to that goal.”
The NDA submission includes data from the LANDSCAPE and NEST
development programs for zuranolone. The LANDSCAPE program includes
five studies of zuranolone in adults with MDD (MDD-201B, MOUNTAIN,
SHORELINE, WATERFALL, and CORAL Studies). The NEST program includes
two studies of zuranolone in adult women with PPD (ROBIN and
SKYLARK Studies).
Zuranolone was granted Fast Track Designation by the FDA in 2017
and Breakthrough Therapy in 2018 for MDD. The FDA also granted Fast
Track Designation for PPD in 2022.
About zuranolone Zuranolone (SAGE-217/BIIB125) is a
once-daily, 14-day, investigational drug in development for the
treatment of major depressive disorder (MDD) and postpartum
depression (PPD). Zuranolone is an oral neuroactive steroid (NAS)
GABA-A receptor positive allosteric modulator (PAM). The GABA
system is the major inhibitory signaling pathway of the brain and
central nervous system and contributes to regulating brain
function. Zuranolone has been granted Fast Track and Breakthrough
Therapy Designation for MDD and Fast Track Designation for PPD by
the U.S. Food & Drug Administration.
Zuranolone is being evaluated in the LANDSCAPE and NEST clinical
development programs. The two development programs include multiple
studies examining use of zuranolone in several thousand people with
a variety of dosing, clinical endpoints, and treatment paradigms.
The LANDSCAPE program includes five studies of zuranolone in people
with MDD (MDD-201B, MOUNTAIN, SHORELINE, WATERFALL, and CORAL
Studies). The NEST program includes two placebo-controlled studies
of zuranolone in women with PPD (ROBIN and SKYLARK Studies).
Additionally, Shionogi completed a Phase 2 study of zuranolone in
Japan in people with MDD.
About Sage Therapeutics Sage Therapeutics is a
biopharmaceutical company fearlessly leading the way to create a
world with better brain health. Our mission is to pioneer solutions
to deliver life-changing brain health medicines, so every person
can thrive. For more information, please visit www.sagerx.com.
About Biogen As pioneers in neuroscience, Biogen
discovers, develops, and delivers worldwide innovative therapies
for people living with serious neurological diseases as well as
related therapeutic adjacencies. One of the world’s first global
biotechnology companies, Biogen was founded in 1978 by Charles
Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize
winners Walter Gilbert and Phillip Sharp. Today, Biogen has a
leading portfolio of medicines to treat multiple sclerosis, has
introduced the first approved treatment for spinal muscular
atrophy, and developed the first and only approved treatment to
address a defining pathology of Alzheimer’s disease. Biogen is also
commercializing biosimilars and focusing on advancing one of the
industry’s most diversified pipelines in neuroscience that will
transform the standard of care for patients in several areas of
high unmet need.
We routinely post information that may be important to investors
on our website at www.biogen.com. Follow us on social media -
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Sage Therapeutics Safe Harbor Various statements in this
release concern Sage's future expectations, plans and prospects,
including without limitation our statements regarding: the
potential profile and benefit of zuranolone in the treatment of MDD
and PPD; our belief that the data from our clinical programs
support the potential of zuranolone in the treatment of MDD and
PPD; our mission of making zuranolone available as a new treatment
option in the treatment of MDD and PPD; the potential for approval
of zuranolone in the treatment of MDD and PPD; our estimates of the
number of people with MDD and PPD; and other statements as to our
mission and goals. These statements constitute forward-looking
statements as that term is defined in the Private Securities
Litigation Reform Act of 1995. 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: the FDA may find inadequacies
and deficiencies in our NDA for zuranolone, including in the data
we submit, despite prior discussions, and may decide not to accept
the NDA for filing; even if the FDA accepts the NDA for filing, the
FDA may find that the data included in the NDA are not sufficient
for approval and may not approve the NDA; the FDA may decide that
the design, conduct or results of our completed and ongoing
clinical trials for zuranolone, even if positive, are not
sufficient for approval in MDD or PPD and may require additional
trials or data which may significantly delay and put at risk our
efforts to obtain approval and may not be successful; the FDA may
not grant priority review or meet expected review timelines for our
NDA; other decisions or actions of the FDA or other regulatory
agencies may affect our efforts with respect to zuranolone and our
plans, progress or results; results of ongoing or future studies
may impact our ability to obtain approval of zuranolone or impair
the potential profile of zuranolone; unexpected concerns may arise
from additional data, analysis or results from any of our completed
studies; 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; the number of patients with MDD and PPD,
the unmet need for additional treatment options and the potential
profile and market for zuranolone in the treatment of MDD and PPD,
if approved, may be significantly smaller than we expect; and we
may encounter technical and other unexpected hurdles which may
delay our timing or change our plans, increase our costs or
otherwise negatively impact our efforts to gain approval of
zuranolone and to make it available as a treatment option for MDD
and PPD or to accomplish other aspects of our mission and goals; as
well as those risks more fully discussed in the section entitled
"Risk Factors" in our most recent quarterly report with the
Securities and Exchange Commission (SEC), as well as discussions of
potential risks, uncertainties, and other important factors in our
subsequent filings with the SEC. 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.
Biogen Safe Harbor This news release contains
forward-looking statements, including statements made pursuant to
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995, relating to the potential, benefits, safety and
efficacy of zuranolone; the potential clinical effects of
zuranolone; the clinical development program for zuranolone;
clinical development programs, clinical trials and data readouts
and presentations for zuranolone; the potential treatment of MDD
and PPD; the potential of Biogen’s commercial business and pipeline
programs, including zuranolone; the anticipated benefits and
potential of Biogen’s collaboration arrangement with Sage; and
risks and uncertainties associated with drug development and
commercialization. These forward-looking statements may be
accompanied by words such as “aim,” “anticipate,” “believe,”
“could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,”
“potential,” “possible,” “will,” “would” and other words and terms
of similar meaning. Drug development and commercialization involve
a high degree of risk and only a small number of research and
development programs result in commercialization of a product.
Results in early-stage clinical trials may not be indicative of
full results or results from later stage or larger scale clinical
trials and do not ensure regulatory approval. You should not place
undue reliance on these statements, or the scientific data
presented.
These statements involve risks and uncertainties that could
cause actual results to differ materially from those reflected in
such statements, including without limitation, uncertainty of
success in the development and potential commercialization of
zuranolone; unexpected concerns may arise from additional data,
analysis or results of clinical studies of zuranolone; regulatory
authorities may require additional information or further studies,
or may fail or refuse to approve or may delay approval of Biogen’s
drug candidates, including zuranolone; the occurrence of adverse
safety events; the risks of other unexpected hurdles, costs or
delays; failure to protect and enforce data, intellectual property
and other proprietary rights and uncertainties relating to
intellectual property claims and challenges; product liability
claims; third party collaboration risks; and the direct and
indirect impacts of the ongoing COVID-19 pandemic on our business,
results of operations and financial condition. The foregoing sets
forth many, but not all, of the factors that could cause actual
results to differ from Biogen’s expectations in any forward-looking
statement. Investors should consider this cautionary statement as
well as the risk factors identified in Biogen’s most recent annual
or quarterly report and in other reports Biogen has filed with the
U.S. Securities and Exchange Commission. These statements are based
on Biogen’s current beliefs and expectations and speak only as of
the date of this news release. Biogen does not undertake any
obligation to publicly update any forward-looking statements,
whether as a result of new information, future developments or
otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20221205005815/en/
MEDIA: Sage Kathryn Ritzinger +1 646 872-2912
Kathryn.Ritzinger@sagerx.com
Biogen Jack Cox + 1 210 544 7920
public.affairs@biogen.com
INVESTORS: Sage Helen Rubinstein +1 315 382-3979
Helen.Rubinstein@sagerx.com
Biogen Mike Hencke +1 781 464 2442 IR@biogen.com
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