Improvement in measurements of overall quality
of life, functioning and general well-being achieved at Day 15 and
sustained at Day 42
Consistent and differentiated safety and
tolerability profile seen across clinical programs
Sage to host conference call on October 4, 2021
at 8:00am ET
Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq:
BIIB) today announced new data from the LANDSCAPE and NEST clinical
development programs evaluating the efficacy and safety of
zuranolone for the treatment of major depressive disorder (MDD) and
postpartum depression (PPD) presented at the 34th European College
of Neuropsychopharmacology (ECNP) Congress, taking place October
2-5, 2021. Presentations include data from the WATERFALL Study, a
Phase 3 placebo-controlled trial evaluating the efficacy and safety
of zuranolone 50 mg in adults 18 to 64 years old with MDD as well
as the open-label SHORELINE Study in MDD and cross-study analyses
from across the LANDSCAPE and NEST programs. Collectively, the
studies show reductions in depressive symptoms with
zuranolone-treated patients such as consistent improvements in
depressive mood, as well as rapid onset of significant effect by
Day 3. Zuranolone has demonstrated a consistent safety profile in
the totality of clinical data to date, with no evidence of
withdrawal, weight gain, sexual dysfunction, euphoria, or sleep
disruption; symptoms that are typically the cause of treatment
discontinuation with current standard of care antidepressants. In
pooled analyses from the LANDSCAPE and NEST programs of SF-36v2, a
patient self-reported measure of general health, zuranolone
treatment led to rapid improvement in quality of life and overall
health across all functioning and well-being domains at Day 15 and
across all domains at Day 42 (Day 45 in ROBIN Study).
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Additional data presented summarized clinical data from the
literature on onset of effect of current treatment options in MDD
demonstrating there is a need for new treatment options with the
potential for rapid response.
“The collection of data presented at ECNP showcases the
LANDSCAPE and NEST programs, in totality, where we have seen a very
consistent and differentiated profile for zuranolone. The efficacy
data across the clinical development programs have demonstrated a
rapid onset of activity, consistent reductions in depressive
symptoms and a two-week treatment regimen that may offer the
potential to treat-as-needed. The data also include a robust safety
database with more than 3,500 patients treated, showing that
zuranolone has been well tolerated to date,” said Steve Kanes,
M.D., PhD., chief medical officer at Sage Therapeutics. “We believe
these data represent the potential for a benefit-risk profile for
zuranolone that may be differentiated from the most prescribed
depression drugs on the market, and may be welcomed by patients, if
approved.”
“The data presented at ECNP further emphasize that zuranolone
dosed once daily for two weeks has the potential to produce a rapid
reduction of depressive symptoms within days for both major
depressive disorder and postpartum depression and a differentiated,
well-characterized safety profile,” said Katherine Dawson, M.D.,
head of the Therapeutics Development Unit at Biogen. “Collectively
these data represent positive steps in Biogen’s journey to expand
our footprint in neuropsychiatry and innovate for the millions of
people who need new options to address mental health
conditions.”
“The efficacy and safety data observed with zuranolone across
the LANDSCAPE and NEST clinical programs indicate that, if
approved, it may offer the potential for people with MDD and PPD to
experience a rapid reduction in their depressive symptoms without
side effects such as weight gain, sexual dysfunction and sleep
disruption that are often associated with treatments currently on
the market,” said Anita H. Clayton, M.D., Chair of Psychiatry and
Neurobehavioral Sciences, University of Virginia School of
Medicine. “Patients in the trials are also indicating through the
patient outcome measures that zuranolone helped with their overall
well-being.”
Data presented at ECNP:
- Oral Presentation: Zuranolone in major depressive
disorder: topline results from the Phase 3, multicenter,
randomized, double-blind, placebo-controlled WATERFALL Study
- Poster Presentation Title: Zuranolone 30 mg in major
depressive disorder: results through 1-year follow-up from the
Phase 3, open-label, SHORELINE Study
- Poster Presentation: Exploring the rapidity of treatment
effect for current treatment options for major depressive
disorder
Conference Call Information
Sage will host a conference call and webcast Monday, October 4,
2021 at 8:00am ET to review the totality of the data presented at
ECNP from the zuranolone clinical development programs. Anita
Clayton, M.D., Chair of Psychiatry and Neurobehavioral Sciences,
University of Virginia School of Medicine will join the conference
call to discuss data presented at the ECNP Congress in more
detail.
The live webcast can be accessed on the investor page of Sage's
website at investor.sagerx.com. A replay of the webcast will be
available on Sage's website approximately two hours after the
completion of the event and will be archived for up to 30 days.
About the Short-Form Health Survey (SF-36)
The Short Form health survey (SF-36) is an often-used,
well-researched, and self-reported measure of general health. The
SF-36 uses 36 questions, covering eight domains of health, to
assess the general health status and quality of life at the
individual level in clinical practice and research, and at the
population level for health policy evaluations. The SF-36 has been
used in thousands of research studies, and while it was originally
designed as a generic health measure, it is also applied to
specific disease populations. The SF-36 represents an international
benchmark for health outcomes measurement and has been used as
efficacy endpoints in clinical trials.
About Major Depressive Disorder (MDD)
Major depressive disorder (MDD) is a common but serious mood
disorder in which people experience depressive symptoms that impair
their social, occupational, educational, or other important
functioning, such as a depressed mood or loss of interest or
pleasure in daily activities, consistently for at least a two-week
period. It is estimated that approximately 19 million people in the
U.S. and more than 250 million people worldwide suffer from MDD
each year. While antidepressants are widely used to treat MDD,
large-scale studies have demonstrated the need for additional
therapies with a differentiated profile.
About Zuranolone
Zuranolone (SAGE-217/BIIB125) is a once-daily, two-week,
investigational drug in development for the treatment of major
depressive disorder (MDD) and postpartum depression (PPD).
Zuranolone is an investigational 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 Breakthrough Therapy
Designation by the U.S. Food & Drug Administration.
Zuranolone is being evaluated as a potential rapid-acting
treatment for PPD and MDD in the NEST and LANDSCAPE clinical trial
programs. The two development programs include multiple studies
examining use of zuranolone in several thousand patients with a
variety of dosing, clinical endpoints, and treatment paradigms. The
LANDSCAPE program includes five studies of zuranolone in patients
with MDD. Data have been reported from three studies of zuranolone
30 mg in patients with MDD (MDD-201B, MOUNTAIN Study and the 30 mg
cohort from the ongoing SHORELINE Study), and one study of
zuranolone 50 mg in patients with MDD (WATERFALL Study) in addition
to an interim cut of the zuranolone 50mg cohort of the ongoing
SHORELINE Study. Two additional studies evaluating zuranolone 50 mg
in patients with MDD are expected to read out by the end of 2021
(CORAL Study and another cut of the 50mg cohort of the SHORELINE
Study).
The NEST Program includes two placebo-controlled studies of
zuranolone in patients with PPD. Positive data from the ROBIN Study
(zuranolone 30 mg) have been previously reported. The SKYLARK Study
(zuranolone 50 mg) is anticipated to readout by mid-2022.
The programs are designed to generate data to support a
potential NDA filing as efficiently as possible. If successful,
LANDSCAPE and NEST may support paths to approval with three
distinct opportunities to address patient needs: PPD, acute rapid
response therapy in MDD when co-initiated with a new standard
antidepressant, and as-needed treatment of MDD.
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.
About Biogen
At Biogen, our mission is clear: we are pioneers in
neuroscience. Biogen discovers, develops and delivers worldwide
innovative therapies for people living with serious neurological
and neurodegenerative 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, Kenneth Murray and Nobel Prize winners Walter Gilbert and
Phillip Sharp. Today Biogen has the leading portfolio of medicines
to treat multiple sclerosis, has introduced the first approved
treatment for spinal muscular atrophy, commercializes biosimilars
of advanced biologics and is focused on advancing research programs
in multiple sclerosis and neuroimmunology, Alzheimer’s disease and
dementia, neuromuscular disorders, movement disorders,
ophthalmology, neuropsychiatry, immunology, acute neurology and
neuropathic pain.
We routinely post information that may be important to investors
on our website at www.biogen.com. Follow us on social media -
Twitter, LinkedIn, Facebook, YouTube.
Forward-Looking Statements
Sage Therapeutics Safe Harbor
Various statements in this release concern Sage's future
expectations, plans and prospects, including without limitation
statements regarding: the potential for future regulatory approval
of zuranolone; our planned timing for reporting of data from
ongoing clinical trials; the potential profile and benefit of
zuranolone in MDD and PPD; regulatory filing plans and potential
pathways and opportunities; planned next steps for the program; our
estimates as to the number of patients with MDD; and the goals,
opportunity and potential for zuranolone and for our business.
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: success in earlier clinical trials may not be repeated
or observed in ongoing or future studies, and ongoing and future
clinical trials may not meet their primary or key secondary
endpoints or generate results sufficient to file for or gain
regulatory approval to market a product without further development
work; unexpected concerns may arise from additional data, analysis
or results from any of our completed studies; we may encounter
adverse results or 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 delays in conduct of our clinical trials,
including slower than expected site initiation or enrollment, that
may impact our ability to meet our expected time-lines; the FDA may
ultimately decide that the design, conduct or results of our
completed, ongoing and planned clinical trials for zuranolone, even
if positive, are not sufficient for regulatory filing or approval
in the indications that are the focus of our development plan and
may require additional trials or data which may significantly delay
our efforts to obtain approval and may not be successful; other
decisions or actions of the FDA or other regulatory agencies may
affect the zuranolone program and our plans, progress or results;
the actual size of the MDD patient population may be significantly
lower than our estimates and, even if zuranolone is approved, it
may only be approved or used to treat a subset of the relevant
patient populations; we may encounter technical and other
unexpected hurdles in the development and manufacture of zuranolone
or our other product candidates 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.
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; results from the
WATERFALL and SHORELINE Studies 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 obtained during the WATERFALL and SHORELINE
Studies or the other 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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SAGE MEDIA CONTACT: Maureen L. Suda (617) 949-4289
Maureen.Suda@sagerx.com
BIOGEN MEDIA CONTACT: Ashleigh Koss Tel: +1 908-205-2572
public.affairs@biogen.com
SAGE INVESTOR CONTACT: Helen Rubinstein (315) 382-3979
Helen.Rubinstein@sagerx.com
BIOGEN INVESTOR CONTACT: Mike Hencke +1 781 464 2442
IR@biogen.com
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