In the zuranolone 50 mg cohort, the majority of
patients who responded to an initial 14-day course received only
one two-week course of treatment during the study and nearly 80%
received only one or two treatment courses in total
Zuranolone 50 mg was generally well-tolerated
with an overall adverse event profile consistent with data reported
earlier and 6.5% of patients discontinuing study drug due to
adverse events
Across the LANDSCAPE clinical program to date,
zuranolone has consistently demonstrated rapid and sustained
improvements in depressive symptoms and a well-tolerated safety
profile
Sage Therapeutics, Inc. (Nasdaq: SAGE), and Biogen Inc. (Nasdaq:
BIIB) today announced 12-month data for the cohort of patients
(n=199), who received zuranolone 50 mg once nightly for 14-days as
their initial dose in the ongoing Phase 3 open-label SHORELINE
Study and had the opportunity to be followed for 12-months. The
SHORELINE Study, part of the LANDSCAPE clinical program, was
designed to naturalistically follow adult patients with major
depressive disorder (MDD) and evaluate the safety and tolerability
of zuranolone as well as the need for repeat dosing for up to one
year. For the primary endpoint of safety and tolerability, the data
analyzed to date show zuranolone was generally well-tolerated, with
no new safety findings or trends identified in the long-term safety
data available regardless of the number of courses of zuranolone a
patient received. Zuranolone has consistently demonstrated rapid
and sustained improvements in depressive symptoms and a
well-tolerated safety profile throughout the LANDSCAPE clinical
program.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20211201005365/en/
Secondary endpoints included the percentage of patients who
received repeat dosing with zuranolone as well as response and
remission as evaluated by the 17-item Hamilton Rating Scale for
Depression (HAMD-17). In the zuranolone 50 mg cohort, nearly 75% of
patients responded to the initial 2-week treatment course. Of those
who responded to the initial course and continued in the study,
approximately 80% of those patients received at most one additional
zuranolone treatment during their time in the study.
The SHORELINE Study, with nearly 1,000 patients enrolled to
date, is comprised of multiple cohorts, including a completed
cohort with zuranolone 30 mg as a starting dose (data previously
reported in 2020 and earlier in 2021) and an ongoing cohort with
zuranolone 50 mg as a starting dose; both cohorts are administered
zuranolone once nightly for 14 days. Enrollment of an anticipated
300 additional patients in the 50 mg cohort is ongoing. The study
provides real-world insight into the potential use of zuranolone,
if approved, as an as-needed treatment for MDD and builds on the
data assembled in the LANDSCAPE clinical program to date. Data from
the LANDSCAPE clinical program has been presented at numerous
medical and scientific conferences and the Companies plan to
present additional data from the ongoing SHORELINE Study in future
scientific forums.
“We believe zuranolone has the potential to offer an innovative
treatment approach that may enable patients with MDD to experience
reductions in depressive symptoms quickly, achieve related
improvements in functioning and well-being, and maintain long
treatment free intervals without the types of burdensome side
effects that are often associated with discontinuation of standard
of care antidepressants. The SHORELINE Study helps provide
important information on how zuranolone, if approved, could be used
to treat people with MDD,” said Barry Greene, Chief Executive
Officer at Sage Therapeutics. “We are pleased by the progress made
with zuranolone throughout 2021 and the data we have generated in
clinical development to date supports our belief in the overall
profile of zuranolone, and its potential to make a profound
difference in the lives of many patients living with MDD.”
“In the SHORELINE Study, zuranolone was generally well-tolerated
by participants regardless of the number of treatment courses
received during the one-year study,” said Priya Singhal, M.D.,
M.P.H., Head of Global Safety and Regulatory Sciences and Interim
Head of R&D at Biogen. “These new data further reinforce
positive findings from multiple late-stage studies of zuranolone
and underscore the potential of zuranolone as a well-tolerated,
rapid-acting and durable treatment option for depression.”
Zuranolone 50 mg: Summary of One-Year
Results
This cohort of the ongoing Phase 3 SHORELINE Study is evaluating
the safety and tolerability of zuranolone 50 mg in adults 18-75 who
have MDD.
- 199 people with MDD (HAMD-17 ≥20 and Montgomery Asberg
Depression Rating Scale (MADRS) ≥28) were treated with an initial
dose of zuranolone 50 mg once nightly for 14 days and had the
opportunity to be followed for up to one year.
- The mean baseline HAMD-17 score (± SD) at entry into the study
was 25.1 ± 3.29 (n=199).
- At baseline, 81 (40.7%) patients were on pre-existing
antidepressant therapy (ADT) that was continued, while 118 (59.3%)
were not on ADT.
Safety and tolerability of zuranolone 50 mg:
- Zuranolone 50 mg was generally well-tolerated with no new
safety finding or trend identified in the long-term safety data
available to date on patients followed up to one year who received
a single or repeat dosing courses. Safety was assessed during
treatment and in between treatment courses and over multiple
treatment courses to inform tolerability over time and
long-term.
- Over the entire study, 137 of 199 (68.8%) patients who
initiated treatment with zuranolone 50 mg reported at least one
adverse event, similar to the previously reported 30 mg cohort
(68.0%). The majority of patients reported treatment emergent
adverse events (TEAEs) with maximum severity of mild to
moderate.
- The most common TEAEs reported >5% (N, % with TEAE) were
somnolence (32; 16.1%), dizziness (30; 15.1%), headache (25;
12.7%), sedation (20; 10.1%), insomnia (14; 7.0%), nausea (13;
6.5%), and tremor (11; 5.5%).
- The types of TEAEs reported by patients receiving zuranolone 50
mg were similar to those previously reported for zuranolone 30 mg.
The frequency of adverse drug reactions known to be associated with
zuranolone, such as somnolence, dizziness, sedation, and tremor,
were higher in the 50 mg cohort; however, the severity and outcome
of events remained consistent with the 30 mg cohort and the overall
safety profile of zuranolone.
- The percent of patients reporting TEAEs leading to
discontinuation of study drug and withdrawal from study,
respectively, were 6.5% (13/199) and 8.0% (16/199).
- There was no signal for increased suicidal ideation or suicidal
behavior compared to baseline in any study period or dose cohort,
as measured by the Columbia-Suicide Severity Rating Scale
(C-SSRS).
- The overall adverse event profile from this zuranolone 50 mg
cohort is generally consistent with the previously reported
SHORELINE Study data, and the types of TEAEs reported are similar
to what has been reported across the LANDSCAPE clinical
program.
Efficacy of zuranolone 50 mg:
- At Day 15 following the initial 2-week treatment, the HAMD-17
mean change from baseline was -16.0 ± 6.04 (n=185).
- 149 (74.9%) patients achieved response (at least 50% reduction
from baseline) and 80 (40.2%) achieved remission (HAMD ≤7).
- Of the 149 responders, 3 withdrew from the study prior to Day
28, leaving 146 beyond Day 28.
- 79.5% of the 146 patients who responded to the initial 2-week
treatment received at most one additional zuranolone treatment
course during their time in the study.
- 54.8% (N=80) received 1 treatment course in total.
- 24.7% (N=36) received 2 treatment courses in total.
- 10.3% (N=15) received 3 treatment courses in total.
- 6.8% (N=10) received 4 treatment courses in total.
- 3.4% (N=5) received 5 treatment courses in total.
- The proportion of patients receiving zero or at most 1
additional treatment course was similar regardless of use of
antidepressant therapy at baseline.
About the SHORELINE Study
The SHORELINE Study (217-MDD-303) is an ongoing Phase 3,
open-label, 1-year longitudinal study evaluating the safety,
tolerability, and need for repeat dosing with zuranolone in adults
with MDD. The study is comprised of multiple cohorts, including a
completed cohort with zuranolone 30 mg as a starting dose and an
ongoing cohort with zuranolone 50 mg as a starting dose; both
cohorts are administered zuranolone once nightly for 14 days.
Enrollment of an additional 300 patients in the 50 mg cohort is
ongoing. Patients who achieve a response after the first treatment
course are eligible to remain on study with the opportunity to
receive additional treatment courses as needed. The need for
repeated dosing is assessed every 14 days based on the results of a
patient-reported PHQ-9 (≥10) and HAMD-17 (≥20) assessment. There is
a minimum of 56 days between zuranolone 14-day courses, to allow
for a maximum of five courses over the 12-month study period. The
complete 12-month data from the zuranolone 30 mg cohort and initial
interim data from the zuranolone 50 mg cohort read out in early
2021.
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 LANDSCAPE and NEST 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 Japan in patients with
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 our
statements regarding: the potential for approval of zuranolone and
our belief in its potential profile, benefit and impact in the
treatment of MDD, if approved; our estimates as to the number of
people with MDD; our future plans and expected activities; and the
mission and goals 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: we
may experience delays or unexpected hurdles in our efforts to seek
approval for zuranolone in the treatment of MDD or PPD; even if we
are successful in our efforts to file a new drug application (NDA)
for zuranolone, 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;
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 of
zuranolone or any of our other product candidates 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 development or our future
plans or potential for success; 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 initiation,
conduct or completion of our ongoing and planned clinical trials,
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; the number of people with MDD and potential market for
zuranolone as a treatment for MDD, if approved, may be
substantially smaller than our estimates; the unmet need for
additional treatment options in MDD and the potential benefit for
zuranolone may not be as significant as we expect; and we may
encounter technical and other unexpected hurdles in the development
and manufacture of zuranolone or any of our other product
candidates which may delay our timing or change our plans or
prospects, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211201005365/en/
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
Sage Therapeutics (NASDAQ:SAGE)
Historical Stock Chart
From Aug 2024 to Sep 2024
Sage Therapeutics (NASDAQ:SAGE)
Historical Stock Chart
From Sep 2023 to Sep 2024