Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq:
BIIB) today announced new analyses from across the development
program for zuranolone, an investigational, oral, once-daily,
14-day treatment in clinical development for adult patients with
major depressive disorder (MDD) and postpartum depression. The 11
new analyses are being presented at the 2022 Psych Congress in New
Orleans, September 17 to 20.
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An analysis from the ongoing open-label, longitudinal SHORELINE
Study in MDD (30 mg cohort n=725, 50 mg cohort n=199) found the
median time to the first repeat treatment course for those patients
who responded to the initial 14-day treatment course was 135 days
for the completed 30 mg cohort (n=489) and 249 days for the ongoing
50 mg cohort (n=146). These data further support zuranolone as a
potential episodic treatment for people with MDD.
Key findings from the completed 30 mg cohort of the SHORELINE
Study, other clinical data and health economics and outcomes
research (HEOR), and patient survey data being presented
include:
- In an analysis of patients in the 30 mg cohort of the SHORELINE
Study with elevated anxiety (n=569) and without elevated anxiety
(n=156), there was a mean reduction in the 17-item Hamilton Rating
Scale for Depression (HAMD-17) total score from baseline to Day 15;
for those patients who had a HAMD-17 response at Day 15 and
continued in the study beyond Day 28, scores remained below
baseline through Day 70 independent of the presence of elevated
anxiety at baseline.
- Among patients with and without elevated anxiety in the 30 mg
cohort of the SHORELINE Study who responded to the initial 14-day
treatment at Day 15 (≥ 50% reduction in HAMD-17 total score),
approximately 70% of patients received 1 or 2 total treatment
courses through their time in the study. Patients had the
opportunity for follow-up for up to 1 year.
- In patients who completed 1 year of follow-up in both cohorts
of the SHORELINE Study (n=407), most had minimal or mild depressive
symptoms at study exit as assessed by the Clinical Global
Impressions-Severity scale.
- Zuranolone was generally well-tolerated with a safety profile
consistent with prior clinical studies. The most common adverse
events associated with zuranolone included headache, somnolence,
dizziness and sedation.
- Data from a post-hoc analysis of 4 studies in the LANDSCAPE
program demonstrated that improvements in depressive symptoms with
zuranolone at Day 15 were sustained beyond the end of
treatment.
- A post-hoc analysis of the WATERFALL Study in MDD evaluated the
statistically significant reduction in depressive symptoms as
measured by HAMD-17 at Day 15 as well as rapid onset observed at
Day 3 and Day 8 with zuranolone 50 mg compared to placebo suggested
that the differences were clinically meaningful according to
estimates of minimal important difference.
- Results from a cross-sectional survey of U.S. adults with
depression (n=715), highlighted unmet needs in the treatment of
MDD. The characteristics rated as either very or extremely
important by the majority of participants were the prevention of
depression symptoms returning, fewer side effects, a treatment
supported by a body of research on safety and efficacy, the ability
to discontinue drug without withdrawal symptoms, works quickly, and
can be repeated if symptoms recur.
- Health economics data showed that patients with MDD who also
received a prescription for anxiety medication incurred over twice
the annual all-cause healthcare costs than those without an anxiety
prescription medication.
“The data presented at Psych Congress highlight the rapid and
sustained improvement in depressive symptoms seen with zuranolone
in clinical trials and reinforce its potential to be an as-needed
treatment in MDD,” said Dr. Greg Mattingly, Associate Clinical
Professor, Washington University. “Depression is a leading
contributor of disability worldwide and importantly awareness has
grown during the past few years of the global pandemic. We can and
must do more to help people living with MDD and those that care
about them overcome the challenges of this disease.”
The 11 Sage and Biogen data presentations at Psych Congress
were:
SHORELINE Study Presentations:
- Assessing the Need for Repeat Treatment Courses with Zuranolone
in Adult Patients With Major Depressive Disorder With Elevated
Anxiety: An Analysis of the Open-Label, Phase 3 SHORELINE
Study
- Safety, Tolerability, and Efficacy of Zuranolone Repeat
Treatment Courses in Adult Patients With Major Depressive
Disorder–An Analysis of the Open-Label, Phase 3 SHORELINE
Study
- Safety and Efficacy of Zuranolone 50 mg and Need for Repeat
Treatment Courses in the Open-label, Phase 3 SHORELINE Study of
Adult Patients With Major Depressive Disorder
- Safety and Efficacy of Zuranolone in Young Adults With Major
Depressive Disorder: A Subgroup Analysis of the Open-Label,
Long-Term, Phase 3 SHORELINE Study
- Depressive Symptom Severity in Patients with Major Depressive
Disorder (MDD) at Study Exit in the One-Year SHORELINE Study of
Episodic Treatment with Zuranolone
LANDSCAPE Program Cross-Study Presentations:
- Sustained Benefits of Zuranolone in Patients With Major
Depressive Disorder: Results From the LANDSCAPE Clinical
Development Program
- Efficacy and Safety of Zuranolone in Adults With Major
Depressive Disorder With and Without Use of Standard-of-Care
Antidepressants at Baseline in the LANDSCAPE Clinical Development
Program
Health Economics and Outcomes Research Presentations:
- Perspectives on the Desirable Attributes Associated With a New
Pharmacotherapy for Major Depressive Disorder: Results From a
Patient Survey
- Zuranolone in Major Depressive Disorder (MDD): Minimal
Important Difference (MID) and Meaningful Change Threshold (MCT) on
the 17-item Hamilton Rating Scale for Depression (HAMD-17)
- Economic Burden Among Individuals with Major Depressive
Disorder Utilizing Anti-Anxiety Medications in the United
States
- Healthcare Resource Utilization in 6 Weeks Post-Diagnosis Among
Individuals with Major Depressive Disorder in the United
States
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 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 -
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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; the potential for zuranolone to become a new treatment option
in the treatment of 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: we may never gain regulatory
approval of zuranolone as a treatment for MDD or PPD; we may not be
successful in filing a new drug application (NDA) for zuranolone in
these indications; even if we complete the NDA filing, the FDA may
find that the data included in the NDA are not sufficient for
acceptance of the filing for review or 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; 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 or use of zuranolone that
negatively impact further development or the potential for approval
or impair the potential profile of zuranolone, and such events may
require additional nonclinical and clinical work which may not
yield positive results; the profile and potential benefits of
zuranolone in the treatment of MDD and PPD, if approved, may be
different than the results seen in our clinical trials and may not
meet our current expectations; the unmet need for additional
treatment options in MDD and PPD and the potential market and
market acceptance for zuranolone in the treatment of these
indications, if approved, may be significantly smaller than we
expect; and we may encounter technical and other unexpected hurdles
which may negatively impact our efforts to gain approval of
zuranolone and to make it available as a treatment option for
depression 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/20220918005062/en/
MEDIA: Sage Becky Kern + 1 914 772 2310
Becky.Kern@sagerx.com
Biogen Dan Haro + 1 617 914 6936
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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