Patients receiving zuranolone 50 mg in the
WATERFALL Study demonstrated rapid improvements in depressive and
anxiety symptoms, as early as the first measured timepoint (Day 3
for HAMD-17 and Day 8 for HAM-A), with average improvements
maintained through the end of the study (Day 42)
Safety data from the WATERFALL Study was
consistent with the zuranolone safety profile seen to date across
the LANDSCAPE program
Zuranolone was generally well-tolerated in a
subgroup of patients aged 65 years and older in the SHORELINE
Study, showing similar efficacy and safety results in the datasets
analyzed to that observed in the general study population
Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq:
BIIB) today announced new data from the LANDSCAPE clinical program
evaluating the efficacy and safety of zuranolone for the treatment
of major depressive disorder (MDD) presented at the American
College of Neuropsychopharmacology (ACNP) Congress taking place
December 5-8 in San Juan, Puerto Rico. Data from the SHORELINE and
WATERFALL Studies in the LANDSCAPE clinical program further the
understanding of the potential efficacy and safety profile of
zuranolone for the treatment of MDD. Across the studies, zuranolone
treatment led to improvements in depressive symptoms as well as in
symptoms of elevated anxiety as assessed by multiple scales
(HAMD-17, MADRS and HAM-A, respectively). In the WATERFALL Study, a
rapid onset of effect in HAMD-17 was observed compared to placebo
as early as Day 3, reaching statistical significance, followed by a
stabilization of depressive symptoms through the follow-up
period.
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Zuranolone has demonstrated a consistent safety profile in the
totality of clinical data to date, with no increased incidence of
adverse events (AEs) of weight gain, sexual dysfunction, or sleep
disruption relative to placebo, symptoms that are often the cause
of standard of care antidepressant discontinuation. In an analysis
of a subgroup of patients (N=96) over the age of 65 in the
SHORELINE Study, zuranolone efficacy and safety results for the
initial 2-week dose treatment course were similar to that of the
general study population. At the time of the analysis, retreatment
data were only available for the zuranolone 30 mg cohort of the
SHORELINE Study. In a subgroup of patients 65 years and older who
responded to the initial 2-week treatment course of zuranolone 30
mg, and were followed for up to one year in the SHORELINE Study,
more than half did not receive a second course of treatment during
their time in the study.
“The data shared at ACNP continue to provide insight to help us
better understand how zuranolone could impact the treatment of
depression and potentially differentiate further from current
antidepressants, if approved,” said Barry Greene, Chief Executive
Officer at Sage Therapeutics. “The analysis conducted evaluating
zuranolone’s effects on measures of anxiety in patients with MDD is
critical. Symptoms of anxiety are highly present in patients with
depression, which can pose unique challenges to care. We are also
pleased with the data for those 65 and older, who can struggle with
current therapies to treat their depression. Zuranolone has
consistently demonstrated rapid and sustained improvements in
depressive symptoms and a well-tolerated safety profile in our
clinical trials to date without the adverse events that are often
associated with discontinuation of standard of care
antidepressants.”
ACNP presentations included data from the WATERFALL Study, a
Phase 3 placebo-controlled trial that evaluated the efficacy and
safety of zuranolone 50 mg in adults 18 to 64 years old with MDD as
well as the ongoing open-label SHORELINE Study in MDD. In an oral
session, an analysis from the WATERFALL Study assessing zuranolone
(50 mg) on symptoms of anxiety as measured by the Hamilton Anxiety
Rating Scale (HAM-A) showed improvements in symptoms of anxiety
compared with placebo at Days 8 and 15. Additional data presented
provided an efficacy analysis from the WATERFALL Study as measured
by the Montgomery-Åsberg Depression Rating Scale (MADRS) total
score, which addresses core mood symptoms such as sadness, lack of
energy, and suicidal thoughts. The group of patients receiving
zuranolone (50 mg) showed rapid improvements in depressive symptoms
and anxiety symptoms, as early as the first measured timepoint (Day
3 for HAMD-17 and Day 8 for HAM-A). Similar results have been
observed across the LANDSCAPE program. Additionally, data from the
SHORELINE Study support the potential of zuranolone as an oral,
as-needed treatment for patients with MDD, including those age 65
and older
“The new data shared at ACNP further our confidence in the
potential of zuranolone to help rapidly mitigate various symptoms
associated with depression, including elevated anxiety,” said Priya
Singhal, M.D., M.P.H., Head of Global Safety and Regulatory
Sciences and Interim Head of Research and Development at Biogen.
“As we continue to evaluate the totality of the data from the
LANDSCAPE clinical develop program – which includes the Phase 3
WATERFALL and SHORELINE Studies – we aim to gain a more
comprehensive understanding of how zuranolone may one day be a
valuable option for people worldwide who seek a new way to treat
depression.”
Data presented at ACNP:
- Oral Presentation & Poster: Improvement in Symptoms
of Depression and Anxiety With Zuranolone Treatment in Patients
With Major Depressive Disorder: HAM-A Analysis From the Phase 3,
Multicenter, Randomized, Double-Blind, Placebo-Controlled WATERFALL
Study
- Poster Presentation: Improvement in Severity and
Symptoms of Major Depressive Disorder With Zuranolone Assessed by
MADRS: Results From the Phase 3, Multicenter, Randomized,
Double-Blind, Placebo-Controlled WATERFALL Study
- Poster Presentation: Zuranolone in Major Depressive
Disorder: Safety and Tolerability Results From the Phase 3,
Multicenter, Randomized, Double-Blind, Placebo-Controlled WATERFALL
Study
- Poster Presentation: Zuranolone in Major Depressive
Disorder: Results From the Phase 3, Multicenter, Randomized,
Double-Blind, Placebo-Controlled, WATERFALL Study
- Poster Presentation: Zuranolone in the Treatment of
Major Depressive Disorder in Patients ≥65 Years of Age: Outcomes
From the Phase 3, Naturalistic SHORELINE Study
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 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 (MDD-201B, MOUNTAIN, SHORELINE,
WATERFALL, and CORAL Studies). The NEST program includes two
placebo-controlled studies of zuranolone in patients with PPD
(ROBIN and SKYLARK Studies). Additionally, Shionogi recently
completed a Phase 2 study of zuranolone in MDD in Japan.
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
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 the leading portfolio
of medicines to treat multiple sclerosis, has introduced the first
approved treatment for spinal muscular atrophy, and is providing
the first and only approved treatment to address a defining
pathology of Alzheimer’s disease. Biogen is also commercializing
biosimilars and focusing on advancing the industry’s most
diversified pipeline in neuroscience that will transform the
standard of care for patients in several areas of high unmet
need.
In 2020, Biogen launched a bold 20-year, $250 million initiative
to address the deeply interrelated issues of climate, health, and
equity. Healthy Climate, Healthy Lives™ aims to eliminate fossil
fuels across the company’s operations, build collaborations with
renowned institutions to advance the science to improve human
health outcomes, and support underserved communities.
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 our
statements regarding: the potential for future regulatory approval
and commercialization of zuranolone; the potential profile and
benefit of zuranolone in MDD; 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: 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 filing or approval of
zuranolone 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; 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; we may
experience negative results in ongoing or future studies of
zuranolone that negatively affect our ability to obtain approval of
zuranolone or that impair the potential profile of zuranolone;
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 which
may substantially impair our efforts; 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; we may encounter delays in development,
including as a result of slower than expected site initiation or
enrollment, the need or decision to expand the trials or other
changes, that may impact our ability to meet our expected timelines
and increase our costs; decisions or actions of the FDA or other
regulatory agencies may affect the initiation, timing, design,
size, progress and cost of clinical trials or may impair the
potential for successful development; if approved, zuranolone may
not have the same profile in clinical practice as observed in
clinical trials, and the profile may not meet our expectations or
the expectations of patients, prescribers or payors; the number of
patients with MDD, the unmet need for additional treatment options
and the potential market for zuranolone may be significantly
smaller than we expect; and we may encounter technical and other
unexpected hurdles in the development and manufacture of our
zuranolone and our other product candidates or the
commercialization of our marketed product which may delay our
timing or change our plans, increase our costs or otherwise
negatively impact our business; 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; the clinical development
program for zuranolone; clinical development programs, clinical
trials and data readouts and presentations for zuranolone; the
potential treatment of MDD; 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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SAGE MEDIA: Maureen L. Suda (617) 949-4289
Maureen.Suda@sagerx.com
SAGE INVESTOR: Helen Rubinstein (315) 382-3979
Helen.Rubinstein@sagerx.com
BIOGEN MEDIA: Ashleigh Koss Tel: +1 908-205-2572
public.affairs@biogen.com
BIOGEN INVESTOR: Mike Hencke +1 781 464 2442 IR@biogen.com
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