Zuranolone 50 mg demonstrated a statistically
significant and clinically meaningful improvement in depressive
symptoms at Day 15, the primary endpoint, and at Days 3, 28, and
45, key secondary endpoints
Zuranolone 50 mg was generally well-tolerated
and demonstrated a safety profile consistent with prior studies
Postpartum depression is one of the most common
medical complications during and after pregnancy impacting
approximately 1 in 8 women annually in the U.S.
Sage Therapeutics to host conference call today
at 8:00 am ET
Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq:
BIIB) today announced that the Phase 3 SKYLARK Study of zuranolone,
an investigational oral drug being evaluated in women with
postpartum depression (PPD), met its primary and all key secondary
endpoints. Women treated with zuranolone 50 mg (n=98) demonstrated
a statistically significant and clinically meaningful improvement
in depressive symptoms at Day 15, the primary endpoint, compared to
placebo (n=97) as measured by a change from baseline (CFB) in the
17-item Hamilton Rating Scale for Depression (HAMD-17) total score.
The least-squares (LS) mean (SE) CFB in HAMD-17 total score at Day
15 for women who received zuranolone 50 mg was -15.6 (0.82)
compared with -11.6 (0.82) for women who received placebo (LS mean
difference -4.0 points; p=0.0007).
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“Reducing suffering from postpartum depression as rapidly and
effectively as possible to restore maternal mental health is of the
utmost importance for moms and their babies,” said Dr. Kristina
Deligiannidis, principal investigator of the SKYLARK Study and
Associate Professor, the Feinstein Institutes for Medical Research
in Manhasset, New York. “These encouraging results are another
important step in efforts to develop a novel treatment option for
patients who suffer from this prevalent condition.”
The study met all key secondary endpoints with rapid and
statistically significant improvement in depressive symptoms as
early as Day 3 for participants treated with zuranolone 50 mg
compared to placebo, which was sustained at all measured timepoints
through Day 45 as measured by CFB in HAMD-17 total score.
SKYLARK Study Summary Results
Zuranolone 50 mg
LS Mean HAMD-17 Total Score
CFB
Placebo
LS Mean HAMD-17 Total Score
CFB
LS Mean Difference
p value
Day 15
Primary Endpoint
-15.6
-11.6
-4.0
0.0007
Day 3*
-9.5
-6.1
-3.4
0.0008
Day 28*
-16.3
-13.4
-2.9
0.0203
Day 45*
-17.9
-14.4
-3.5
0.0067
*Key Secondary Endpoint
In addition, the study demonstrated statistically significant
improvement in the key secondary endpoint of change from baseline
in the Clinical Global Impression Severity (CGI-S) scale at Day 15
for participants treated with zuranolone 50 mg as compared to
placebo (zuranolone -2.2 vs. placebo -1.6, p= 0.0052). The CGI-S is
a clinician-administered 7-point scale that rates the severity of a
person’s disease at the time of assessment.
Zuranolone is an investigational two-week, once-daily oral drug
being developed for major depressive disorder (MDD) and PPD. The
SKYLARK Study in PPD was a randomized, double-blind,
placebo-controlled study evaluating the efficacy and safety of
zuranolone 50 mg dosed once daily for 14 days compared to placebo.
Women enrolled in the study (n=200) had a total score of equal to
or greater than 26 at baseline in the HAMD-17 and were followed for
up to 45 days. The study population included approximately 22%
Black or African American women and 38% Hispanic or Latina
women.
Zuranolone 50 mg was generally well-tolerated and demonstrated a
safety profile consistent with that observed in the clinical
development program to date. In women in both treatment groups who
experienced treatment emergent adverse events (TEAEs), the majority
were mild to moderate in severity. The most common TEAEs (>5% in
the zuranolone 50 mg arm) were somnolence, dizziness, sedation,
headache, diarrhea, nausea, urinary tract infection and COVID-19.
No evidence of withdrawal symptoms or increased suicidal ideation
or behavior were identified as assessed by the 20 item Physician
Withdrawal Checklist and the Columbia Suicide Severity Rating
Scale, respectively.
"The positive outcomes of the SKYLARK Study are a critical step
in our mission to help women suffering with postpartum depression
find rapid relief from their depressive symptoms so they can get
back to feeling like themselves,” said Barry Greene, Chief
Executive Officer at Sage. “Postpartum depression can be
devastating for women and their families. If approved, zuranolone
would be the first oral medication specifically indicated to treat
PPD.”
“Postpartum depression is frequently under-recognized, and it
can take time for women to be clinically diagnosed and treated,”
said Katherine Dawson, M.D., Head of the Therapeutics Development
Unit at Biogen. “Our hope is to be able to offer an innovative
treatment option to potentially reduce the overwhelming impact
postpartum depression can have on women and their families.”
PPD is one of the most common medical complications during and
after pregnancy1 and is estimated to affect approximately one in
eight women who have given birth in the U.S. or approximately
500,000 women annually.2 Symptoms of PPD can include depressed
mood, loss of interest in activities, changes in sleep patterns and
appetite, decreased energy, feelings of guilt or worthlessness,
trouble concentrating and in some cases thoughts of suicide.3 While
recognized by the U.S. Department of Health and Human Services as a
high-priority public health issue, screening rates vary and nearly
70% of women with PPD may go undiagnosed.1
“Every day we hear about the devastating consequences PPD and
other perinatal mood disorders have on women and their families,”
said Wendy N. Davis, PhD, PMH-C, Executive Director, Postpartum
Support International. “Access to treatment for women with PPD is
still very low, and promising new medicines that have the potential
to work quickly and specifically could provide an additional option
that is desperately needed.”
The NEST clinical development program for zuranolone in PPD
includes the SKYLARK and ROBIN Studies. The first study in the NEST
program, the Phase 3 ROBIN Study, also met its primary endpoint.
The ROBIN Study was a multicenter, randomized, double-blind,
placebo-controlled study evaluating the efficacy, safety, and
pharmacokinetics of zuranolone 30 mg in the treatment of PPD. The
LANDSCAPE and NEST development program for zuranolone includes 7
clinical studies evaluating the safety and efficacy of zuranolone
in MDD and PPD.
Sage Therapeutics and Biogen have initiated a rolling submission
of a New Drug Application (NDA) to the U.S. Food and Drug
Administration for zuranolone in the treatment of MDD and plan to
complete the MDD NDA filing in the second half of 2022. An
associated NDA filing for PPD is anticipated in early 2023.
Conference Call Information
Sage will host a conference call and webcast on June 1 at 8:00
a.m. ET to review the totality of the SKYLARK Study. 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 SKYLARK Study
The SKYLARK Study (217-PPD-301) was a Phase 3, randomized,
double-blind, placebo-controlled trial assessing the efficacy and
safety of zuranolone 50 mg compared to placebo in adult women with
severe PPD. The 200 patients enrolled in the study were randomized
to receive zuranolone 50 mg or a placebo once nightly for 14 days.
People in the study were then followed for an additional four
weeks. The primary endpoint was the change from baseline in the
17-item Hamilton Rating Scale for Depression (HAMD-17) total score
at Day 15. The companies anticipate further data disclosures at
upcoming meetings and publications. For more information about this
trial, please visit clinicaltrials.gov.
About Postpartum Depression (PPD)
Postpartum depression (PPD) is one of the most common medical
complications during and after pregnancy.1 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 eight women who have given birth in the U.S.
or approximately 500,000 women annually.2
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 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 -
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: plans for completing the NDA filing for
zuranolone in MDD and for submitting an associated NDA filing in
PPD, and the anticipated timing of such activities; the potential
profile and benefit of zuranolone in the treatment of PPD and MDD;
our belief that the data from our clinical programs support the
potential of zuranolone in the treatment of PPD; our mission of
making zuranolone available as a new treatment option in the
treatment of PPD; the potential for approval of zuranolone 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 experience delays or unexpected hurdles in our
efforts to complete the NDA submission for zuranolone in MDD and to
make the associated filing in PPD, and we may not be able to
complete such activities on the timelines we expect or at all; 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 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 need to align with
our collaborators may hamper or delay our development and
commercialization efforts or increase our costs; the number of
patients with PPD, the unmet need for additional treatment options
and the potential market for zuranolone in the treatment of 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 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.
References
- “ACOG Committee Opinion No. 757: Screening for Perinatal
Depression.” Obstetrics and gynecology vol. 132,5 (2018):
e208-e212. doi:10.1097/AOG.0000000000002927
- Bauman BL, et al. Morbidity and Mortality Weekly Report.
2020;69(19):575-581
- American Psychiatric Association. (2013). Diagnostic and
statistical manual of mental disorders (5th
ed.).https://doi.org/10.1176/appi.books.9780890425596
View source
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SAGE MEDIA: Becky Kern (914) 772-2310 Becky.Kern@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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