Results from pivotal trial showed treatment
with SAGE-217 resulted in rapid, clinically meaningful improvement
in major depressive disorder (MDD) symptoms across multiple
measures and time points
SAGE-217 is currently being investigated in the
Phase 3 MOUNTAIN trial for the treatment of MDD, with results
expected in Q4 2019 or Q1 2020
Sage Therapeutics (NASDAQ: SAGE), a biopharmaceutical company
committed to developing novel therapies with the potential to
transform the lives of people with debilitating brain disorders,
today announced that the New England Journal of Medicine (NEJM)
published full results from the double-blind, randomized,
placebo-controlled Phase 2 study evaluating SAGE-217 as a treatment
for major depressive disorder (MDD). In the study, SAGE-217, taken
orally, once daily, showed a rapid, statistically significant
reduction in Hamilton Rating Scale for Depression (HAM-D) total
scores versus placebo beginning the morning following the first
dose (Day 2) and sustained through the primary endpoint of Day 15
(-7.1 difference, p<0.001). At Day 15, 64% of patients who
received SAGE-217 achieved remission, defined as a score of 7 or
less on the HAM-D scale, compared with 26% of patients who received
placebo. Additionally, at Day 15 the HAM-D response rates were
78.6% versus 40.5% in the SAGE-217 and placebo groups,
respectively.
Results published in NEJM also include additional data from
multiple secondary endpoints, all of which generally favored
SAGE-217 at the end of treatment (Day 15). In the study, SAGE-217
was generally well tolerated with a safety profile consistent with
that seen in earlier SAGE-217 trials. Overall reports of treatment
emergent adverse events (TEAEs) were 53.3% in the SAGE-217 group
and 45.5% in the placebo group. No serious adverse events or deaths
occurred during the trial.
“The findings published in the New England Journal of Medicine
suggest the potential for SAGE-217 to be developed as a novel
treatment option for people living with major depressive disorder,”
said Anthony J. Rothschild, M.D., Irving S. and Betty Brudnick
Endowed Chair of Psychiatry, professor of psychiatry and psychiatry
department vice chair for research at the University of
Massachusetts Medical School and an author on the manuscript.
“Current treatments can take many weeks to work yet patients often
experience side effects almost immediately. The significant and
rapid improvements in depression and anxiety symptoms observed with
SAGE-217 in this trial, combined with the response, remission and
safety data, are extremely encouraging for a clinical disorder that
can have such debilitating effects on people’s lives.”
Major depressive disorder causes a persistent feeling of sadness
and loss of interest in daily activities, often affecting how a
person feels, thinks and behaves, and can lead to a variety of
emotional and physical problems. It affects more than 17 million
American adults, or about 6.8% of the U.S. population age 18 and
older in a given year, and is one of the most common, but serious,
mood disorders impacting people of all ages, races, and
socioeconomic status.
“Our ongoing research into the treatment and management of
depression, and other mood disorders, is driven by an ultimate goal
of transforming the lives of people suffering from these
conditions,” said Steve Kanes, M.D., Ph.D., chief medical officer
of Sage Therapeutics. “The Phase 2 results suggest SAGE-217, if
successfully developed, may offer a rapid-acting, well-tolerated,
and durable therapy, which could change the way depression is
treated. The ongoing clinical program for SAGE-217 in major
depressive disorder and postpartum depression is intended to
generate key efficacy and safety information needed to support a
submission for regulatory approval and to further inform use if the
drug is approved.”
About the placebo-controlled pivotal Phase 2 trial of
SAGE-217 in MDD In the randomized, double-blind,
parallel-group, placebo-controlled trial, 89 eligible patients
(with a minimum total score of 22 on the Hamilton Rating Scale for
Depression at baseline) were randomized in a 1:1 ratio to receive
SAGE-217 capsules (30 mg) (n=45) or matching placebo (n=44). All
doses of study drug were administered at night with food. The study
consisted of a 14-day treatment period and a 4-week follow-up
period. The mean HAM-D total scores at baseline were 25.2 for the
SAGE-217 group and 25.7 for the placebo group (overall range
22-33), representing patients with moderate to severe MDD.
Approximately 90% of patients in each group completed the study.
The most common treatment emergent adverse events (≥5%) in the
SAGE-217 group included headache (17.8%), nausea (11.1%), dizziness
(11.1%), and somnolence (6.7%).
About Major Depressive Disorder 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 17 million people in the U.S. suffer from MDD each
year. While antidepressants are widely used to treat MDD,
large-scale studies have demonstrated the need for additional
therapies.
About SAGE-217 SAGE-217 is a next generation positive
allosteric modulator that has been optimized for selectivity to
synaptic and extrasynaptic GABAA receptors and has a
pharmacokinetic profile intended for periods of daily oral dosing.
The GABA system is the major inhibitory signaling pathway of the
brain and central nervous system (CNS), and contributes
significantly to regulating CNS function. SAGE-217 is currently
being developed for major depressive disorder, postpartum
depression, and certain other mood disorders.
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.
Forward-Looking Statements Various statements in this
release concern Sage's future expectations, plans and prospects,
including without limitation: our views, statements and
expectations regarding: the potential timing for reporting results
from the MOUNTAIN study; the goals of our development program for
SAGE-217, and the potential to generate data sufficient to file for
regulatory approval; the potential of SAGE-217 as a future
treatment option in the treatment of MDD and PPD, and the potential
to change treatment paradigms and benefit patients, if SAGE-217 is
successfully developed and approved; our estimates as to the number
of people in the U.S. who suffer from MDD; and the goals and vision
for our programs and potential of 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 not be successful in our development of SAGE-217 or any of our
other current or future product candidates in any indication we are
currently pursuing or may in the future pursue; success in earlier
clinical trials or nonclinical studies may not be repeated or
observed in ongoing or future studies; ongoing and future clinical
or nonclinical results may generate negative results or results
that are otherwise different than we expect which may cause a delay
or curtailment of future development efforts or may not support
further development or be sufficient to file for or gain regulatory
approval; we may decide that a development pathway in one or more
indications is no longer feasible or advisable or that the unmet
need no longer exists; the FDA may decide that a development
program, even if positive, is not sufficient for a new drug
application filing or approval; decisions or actions of the FDA or
other regulatory agencies may affect the initiation, timing,
design, size, progress and cost of clinical trials and our ability
to proceed with further development; we may experience slower than
expected initiation or enrollment in ongoing or future clinical
trials or issues with sites or data collection or generation; we
may encounter unexpected safety or tolerability issues; the number
of people suffering from MDD or the unmet need for additional
treatment options may be significantly smaller than we expect and
our results may not be sufficient to meet the unmet need or to
change treatment paradigms, even if we are successful in our
development efforts; the internal and external costs required for
our ongoing and planned activities, and to build our organization
in connection with such activities, and the resulting use of cash,
may be higher than expected which may cause us to change or curtail
some of our plans; and we may encounter technical and other
unexpected hurdles in our development efforts; as well as those
risks more fully discussed in the section entitled "Risk Factors"
in our most recent quarterly report filed with the Securities and
Exchange Commission (SEC), and 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190904005973/en/
Investor Contact: Matt Calistri, 617-914-2635
matthew.calistri@sagerx.com Media Contact: Jeff Boyle,
617-949-4256 jeff.boyle@sagerx.com
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