Sage Therapeutics Announces Presentation of Promising Results from the Phase 2 LUMINARY Study of SAGE-718 in Patients with Mild Cognitive Impairment and Mild Dementia due to Alzheimer’s Disease
April 01 2022 - 6:30AM
Business Wire
Data to be Presented During the Emerging
Science Session at the American Academy of Neurology’s 74th Annual
Meeting
The LUMINARY Study is a Phase 2, open-label
study evaluating the safety, tolerability and efficacy of SAGE-718
once daily in individuals with mild cognitive impairment and mild
dementia due to Alzheimer’s disease
SAGE-718 demonstrated improvement across
multiple tests of executive performance as well as improvement on
key tests of learning and memory in the LUMINARY Study
Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical
company leading the way to create a world with better brain health,
announced today the presentation of data from the Phase 2 LUMINARY
Study that showed SAGE-718, a first-in-class, oral, positive
allosteric modulator of the NMDA receptor, was generally
well-tolerated and associated with improvement on multiple tests of
executive performance and learning and memory in patients with mild
cognitive impairment (MCI) and mild dementia due to Alzheimer’s
disease (AD). The LUMINARY Study is part of CogNEXT, Sage’s
early-stage trial platform designed to evaluate the therapeutic
potential of SAGE-718 to treat cognitive deficits across a range of
brain health disorders. The data will be presented during the
Emerging Science Session on Tuesday, April 5, at the 74th Annual
Meeting of the American Academy of Neurology (AAN) in Seattle.
“Alzheimer’s disease is one of the greatest areas of unmet
patient need, with an estimated global prevalence of more than 134
million people and few, if any, treatment options to specifically
address mild cognitive impairment and mild dementia,” said Jim
Doherty, Ph.D., Chief Development Officer at Sage. “We are
encouraged by the positive results shared from the LUMINARY Study,
which are consistent with signals suggesting improvement in
cognitive performance seen across the SAGE-718 program, including
in people with Parkinson’s and Huntington’s disease. We look
forward to learning more about the potential of SAGE-718 as we
continue to advance our program with multiple ongoing or planned
Phase 2 studies.”
In the LUMINARY Study, a comprehensive battery of tests was used
to assess multiple domains of cognitive performance in 26 patients
receiving SAGE-718 3 mg once daily for 14 days. At Day 14,
improvements from baseline were observed on multiple tests of
executive functioning (Digit Symbol Substitution, Multitasking, One
Touch Stockings, Spatial Working Memory, and 2-Back tests) and
learning and memory (Pattern Recognition Memory and Verbal
Recognition Memory tests).
Statistically significant improvement in the Montreal Cognitive
Assessment (MoCA) (+2.3 points vs baseline) was observed at Day 28.
As expected, no appreciable effect was observed on measures of
simple attention/psychomotor speed, in keeping with the profile of
SAGE-718 based on data to date. Functional assessments also
captured notable improvement in some patients (Clinical Global
Impressions Scales and Amsterdam Instrumental Activities of Daily
Living Questionnaire), particularly on items measuring aspects of
complex/higher order activities.
SAGE-718 was generally well-tolerated in the LUMINARY Study.
Eight mild/moderate treatment-emergent adverse events (TEAE) were
reported in seven patients. No serious adverse events or deaths
were reported.
About the LUMINARY Study
The LUMINARY Study was an open-label, Phase 2 study evaluating
SAGE-718, 3mg once daily for 14 days in patients with mild
cognitive impairment and mild dementia due to AD. Patients aged
50–80 years with MoCA scores of 15-24 were included.
Treatment-emergent adverse event incidence through Day 28 (primary
endpoint), other safety outcomes (secondary endpoints) and
cognitive and functional assessments were analyzed.
About SAGE-718
SAGE-718, Sage’s first-in-class NMDA receptor PAM and lead
neuropsychiatric drug candidate, is in development as a potential
oral therapy for cognitive disorders associated with NMDA receptor
dysfunction, potentially including Huntington’s disease,
Parkinson’s disease and Alzheimer’s disease. Ongoing studies aim to
evaluate whether SAGE-718 may have the potential to improve
cognitive symptoms for these difficult-to-treat disorders. SAGE-718
is currently being studied in the ongoing Phase 2 DIMENSION Study,
a double-blind placebo-controlled study in people with early to
moderate cognitive impairment due to Huntington’s disease that is
designed to evaluate the efficacy of once-daily dosed SAGE-718 over
three months. Sage expects to initiate additional Phase 2 studies
evaluating SAGE-718 in Huntington’s, Parkinson’s and Alzheimer’s
diseases in 2022. In 2021, SAGE-718 received Fast Track Designation
from the FDA for development of SAGE-718 as a potential treatment
for Huntington’s disease.
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.
Forward-Looking Statements
Various statements in this release concern future expectations,
plans and prospects, including without limitation statements
regarding: Sage’s belief in the potential profile and benefit of
SAGE-718 and the potential impact of findings from the LUMINARY
Study; our goals and plans for further development of SAGE-718 and
the potential for successful development; our estimates as to the
number of patients with Alzheimer’s disease; our belief in the need
for new treatment options for this indication; the goals,
opportunity and potential for the SAGE-718 program; 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: the
positive results from the LUMINARY Study or from other studies we
have conducted with SAGE-718 may not be repeated in future studies
in the indications we have studied to date or in other indications
we may study in the future with SAGE-718, and future clinical
results may not meet their primary or key secondary endpoints;
clinical and nonclinical data we generate in the course of our
development program may not be sufficient to file for or gain
regulatory approval to market SAGE-718 without further development
work or may not support further development at all; we may
encounter adverse results or 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 ongoing or future clinical trials that may
impact our ability to meet our expected time-lines; the FDA may not
agree with our view of the data we generate from our development
efforts at any stage; decisions or actions of the FDA or other
regulatory agencies may affect the initiation, timing, design,
size, or progress of ongoing or future clinical trials and our
ability to proceed with further development; the FDA may ultimately
decide that the design or results of completed and planned clinical
trials, even if positive, are not sufficient for regulatory
approval of SAGE-718 in any indication or of any of our other
product candidates in any indications that are the focus of our
development programs and plans; the actual size of the patient
population in Alzheimer’s disease or in any other indication we
study and the unmet need for new treatment options may be
significantly lower than our estimates and, even if SAGE-718 is
approved for any indication, it may only be approved or used to
treat a subset of the relevant patient population; we may encounter
technical and other unexpected hurdles in the development and
manufacture of SAGE-718 or our other product candidates which may
delay our timing or change our plans; as well as those risks more
fully discussed in the section entitled "Risk Factors" in our most
recent Annual Report on Form 10-K, and 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. Sage explicitly disclaims any obligation to
update any forward-looking statements.
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Investor Contact Helen Rubinstein 315-382-3979
helen.rubinstein@sagerx.com
Media Contact Becky Kern 914-772-2310
Becky.Kern@sagerx.com
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