Zuranolone 50 mg demonstrated a clinically
meaningful and statistically significant improvement in depressive
symptoms at Day 15, the primary endpoint, and at Days 3, 28, and
45, key secondary endpoints as previously reported
Newly presented data offered additional insight
into the SKYLARK Study and further demonstrated the rapid
improvements in depressive symptoms observed in the clinical
trial
Zuranolone was generally well-tolerated, with a
safety profile consistent with previous clinical trials; most
treatment-emergent adverse events (TEAEs) were mild or moderate in
severity in the SKYLARK Study
Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq:
BIIB) today presented additional data from the Phase 3 SKYLARK
Study of zuranolone in adult women with postpartum depression
(PPD), at the 35th European College of Neuropsychopharmacology
(ECNP) Congress, taking place October 15-18, 2022, in Vienna,
Austria. This was the first time the SKYLARK Study was presented at
a medical congress. Zuranolone is an investigational therapy being
evaluated as a once-daily, 14-day oral short course treatment in
adults with major depressive disorder (MDD) and PPD.
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The SKYLARK Study, as previously reported, achieved the primary
and all key secondary endpoints, with study participants
demonstrating rapid and significant improvements in depressive
symptoms as early as Day 3 that were sustained through Day 45.
Women with PPD who were treated with zuranolone 50 mg (n=98) showed
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
(least-squares mean ±SE: zuranolone 50 mg −15.6 ±0.82 vs. placebo
−11.6 ±0.82; [p=0.0007]). The study population was diverse,
including approximately 22% Black or African American women and 38%
identifying ethnically as Hispanic or Latina women.
In the presentation at ECNP, additional secondary endpoint data
demonstrated that a higher proportion of patients in the zuranolone
50 mg arm achieved a HAMD-17 response (≥ 50% decrease from baseline
HAMD-17 total score) as compared with the placebo arm at Days 3, 8,
15, 21, and 28 (p<0.05, at all time points). Data also showed
that a higher proportion of patients in the zuranolone arm achieved
HAMD-17 remission (HAMD-17 total score ≤ 7) than in the placebo arm
from Day 3 through Day 45 (Day 45 p<0.05).
“The results of the SKYLARK Study are incredibly encouraging and
show the potential positive impact zuranolone could have for women
with PPD. Rapid symptom relief is critical for women with PPD,
because delays in treatment efficacy can negatively impact
resolving depressive symptoms and overall clinical outcomes for
mother and baby,” said Dr. Kristina Deligiannidis, Principal
Investigator of the study and Professor, the Feinstein Institutes
for Medical Research in Manhasset, New York. “I’ve seen the
consequences PPD can have on a mother’s ability to care for
herself, her baby, and her family in a way that can have a
generational impact. There are currently no oral therapies approved
for PPD and we desperately need new treatment options to help women
get well as soon as possible and stay well.”
Additional secondary endpoints showed further evidence of the
potential impact of zuranolone on the reduction of other PPD
related symptoms, including anxiety in these patients. Treatment
with zuranolone was shown to significantly improve symptoms of
anxiety at Days 3, 8, 15, and 45 (p<0.05, at all time points)
when compared to placebo as measured by the Hamilton Anxiety Rating
Scale (HAM-A).
In the SKYLARK Study, zuranolone was generally well-tolerated,
with a safety profile consistent with that observed in the clinical
development program to date. The majority of treatment-emergent
adverse events (TEAEs) experienced by women in both treatment
groups were mild to moderate in severity. A total of two
participants (all in the zuranolone group) experienced four serious
adverse events all of which were assessed by the investigator as
unrelated to the therapy. Common TEAEs (>5% in the zuranolone 50
mg arm) were somnolence, dizziness, sedation, headache, diarrhea,
nausea, urinary tract infection and COVID-19.
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 PPD, and
plan to complete the NDA filing in the second half of 2022.
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, 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.
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 PPD, and
plan to complete the NDA filing in the second half of 2022. If
approved, zuranolone would be the first oral medication
specifically indicated to treat PPD.
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.
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 PPD, and the anticipated timing of such
filing; the potential profile and benefit of zuranolone in the
treatment of PPD; our belief that the data from the SKYLARK Study
support the potential of zuranolone in the treatment of 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 PPD, and we
may not be able to complete such filing 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 that negatively impact further development or
the potential or scope of approval 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 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.
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
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221017005338/en/
MEDIA: Sage Becky Kern (914) 772-2310
Becky.Kern@sagerx.com
Biogen Dan Haro + 1 857 259 9880
public.affairs@biogen.com
INVESTORS: Sage Helen Rubinstein (315) 382-3979
Helen.Rubinstein@sagerx.com
Biogen Mike Hencke +1 781 464 2442 IR@biogen.com
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