Sage Therapeutics Announces Phase 2 SURVEYOR Study Reinforces Cognitive Impact of Huntington’s Disease
11 Giugno 2024 - 12:30PM
Business Wire
The SURVEYOR Study met its primary endpoint
demonstrating a statistically significant difference as measured by
the HD-Cognitive Assessment Battery (HD-CAB) composite score at
baseline between healthy participants and participants with
Huntington’s Disease (HD) prior to any treatment with dalzanemdor
(SAGE-718) or placebo; further underscoring the cognitive impact of
HD
For participants with HD that received
dalzanemdor or placebo, dalzanemdor was generally well-tolerated
with no new safety signals observed
Sage Therapeutics announced today topline results from the Phase
2 SURVEYOR Study. The study met its primary endpoint demonstrating
a statistically significant difference as measured by the
HD-Cognitive Assessment Battery (HD-CAB) composite score at
baseline between healthy participants and participants with
Huntington’s Disease (HD) prior to any treatment with dalzanemdor
(SAGE-718) or placebo.
“Huntington’s Disease is a rare, genetic, neurodegenerative
condition that greatly impacts the ability of individuals to
function independently. While symptoms of cognitive impairment can
precede motor symptoms by up to 15 years, it is a historically
underrecognized aspect of HD and there are no approved treatments
for cognitive impairment in HD,” said Laura Gault, Chief Medical
Officer, Sage Therapeutics. “The findings from the SURVEYOR Study
highlight the extent of cognitive impairment associated with HD and
enhance our collective understanding of this devastating disease.
This finding further underscores the importance of developing
treatments that can address this critical unmet need for people
living with HD.”
SURVEYOR (NCT05358821) was a small study with three objectives:
to determine the magnitude of cognitive impairment in HD compared
to healthy participants; to evaluate the safety of dalzanemdor in
participants with HD; and to better understand the relationship
between changes in cognition and changes in function. A total of 40
participants with HD and 29 healthy participants were enrolled. The
HD-CAB, a composite battery comprised of six individual tests to
assess various domains of cognition relevant to HD, was used to
evaluate cognition in all study participants.
SURVEYOR Study Results:
The study met its primary endpoint demonstrating a statistically
significant difference as measured by the HD-CAB composite score at
baseline between healthy participants and participants with
Huntington’s Disease (HD) prior to any treatment with dalzanemdor
or placebo. The baseline composite score for participants with HD
was markedly lower (p < 0.0001) compared to healthy
participants, further underscoring the extent of cognitive
impairment associated with HD and the significant unmet need for
treatment options.
In the second part of the study, participants with HD were
randomly assigned to receive dalzanemdor or placebo for a 28-day
treatment period. The study was not designed or powered to demonstrate a
statistically significant difference between dalzanemdor and
placebo.
- In this part of the study, the safety and tolerability of
dalzanemdor was evaluated as a secondary objective, and exploratory
analyses included measures of cognition and function.
- Dalzanemdor was generally well-tolerated and no new safety
signals were observed. A total of 11 participants with HD
experienced treatment emergent adverse events (TEAEs), the vast
majority of which were mild to moderate in severity. There were no
discontinuations related to TEAEs.
- There was a small numerical difference observed between
dalzanemdor and placebo on the HD-CAB composite score at Day 28.
Other prespecified analyses suggested the potential for
directionally positive signals in a number of individual component
tests of the HD-CAB and in some functional assessments. Additional
work is ongoing to further analyze and understand the data
including the relationship of changes in cognition to changes in
function.
As the Company continues to evaluate the SURVEYOR Study data, it
plans to apply relevant learnings to ongoing work on the
dalzanemdor program. The Company expects the following dalzanemdor
program milestones in late 2024:
- Report topline data from LIGHTWAVE Study in mild cognitive
impairment and mild dementia in Alzheimer’s Disease
- Report topline data from DIMENSION Study in cognitive
impairment associated with HD
About dalzanemdor (SAGE-718)
Dalzanemdor (SAGE-718), a first-in-class investigational NMDA
receptor positive allosteric modulator (PAM), is in development as
a potential oral therapy for cognitive disorders associated with
NMDA receptor dysfunction, including Huntington’s Disease (HD) and
Alzheimer’s Disease (AD). Sage is advancing a clinical program for
dalzanemdor (SAGE-718) with multiple ongoing placebo-controlled
Phase 2 studies across multiple disease areas, including its
potential lead indication, cognitive impairment associated with HD,
as well as mild cognitive impairment and mild dementia in AD. The
Company is also conducting an open-label safety study in HD
cognitive impairment.
About Sage Therapeutics
Sage Therapeutics (Nasdaq: SAGE) is a biopharmaceutical company
committed to our mission of pioneering solutions to deliver
life-changing brain health medicines, so every person can thrive.
Sage developed the only two FDA-approved treatments indicated for
postpartum depression and is advancing a robust pipeline to target
unmet needs in brain health. Sage was founded in 2010 and is
headquartered in Cambridge, Mass. Find out more at www.sagerx.com
or engage with us on Facebook, LinkedIn, Instagram, and X.
Forward-Looking Statements
Various statements in this release concern future expectations,
plans and prospects, including without limitation, statements
regarding: our belief in the potential profile and benefit of
dalzanemdor; the potential impact of findings from the SURVEYOR
Study; our plans for further development of dalzanemdor; our
expectations with respect to the timing of reporting of results
from ongoing clinical trials of dalzanemdor; our belief in the
unmet need for new treatment options for cognitive impairment in
HD; the potential utility of the HD-CAB and other functional
assessments of cognition in HD; the potential for positive results
from ongoing studies of dalzanemdor in HD and AD; our statements as
to the potential for dalzanemdor in the treatment of cognitive
impairment in HD and other neurodegenerative diseases; and the
mission, goals, opportunity and potential 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 results of our ongoing clinical studies of
dalzanemdor in HD and AD may be negative; the ongoing studies of
dalzanemdor may not meet their primary or key secondary endpoints;
potentially directionally positive signals in certain measures of
the treatment phase of the SURVEYOR study may not prove to be
actual signals or meaningful to the development program; positive
signals or results from earlier open-label trials may not be
replicated in ongoing or future trials; clinical and nonclinical
data we generate in the course of the dalzanemdor development
program may not be sufficient to move to the next phase of
development for an indication 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 or reporting of clinical trial results, including as the
result of the need to meet with regulatory authorities, or as a
result of actions arising from those meetings, that may impact our
ability to meet our expected time-lines; the FDA or other
regulatory authorities 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 authorities may affect the
initiation, timing, design, size, or progress of ongoing or future
clinical trials or the regulatory pathway for dalzanemdor in an
indication or our ability to proceed with further development; the
FDA or other regulatory authorities may ultimately decide that the
design or results of completed, ongoing and planned clinical
trials, even if positive, are not sufficient for the next phase of
development or ultimately to file for or receive regulatory
approval of dalzanemdor in any indication or of any of our other
product candidates in any indications that are the focus of our
development programs and plans; even if dalzanemdor is approved for
any indication, it may only be approved or used to treat a subset
of the relevant patient population and may not achieve market
acceptance; we may encounter technical and other unexpected hurdles
in the development and manufacture of dalzanemdor or our other
product candidates which may delay our timing or change our plans
or impact our results; as well as those risks more fully discussed
in the section entitled "Risk Factors" in our most recent Quarterly
Report on Form 10-Q, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240610834762/en/
MEDIA: Sage Therapeutics Francesca Dellelci +1 856 261
5975 Francesca.Dellelci@SageRx.com
INVESTORS: Sage Therapeutics Ashley Kaplowitz +1 786 252
1419 Ashley.Kaplowitz@SageRx.com
Grafico Azioni Sage Therapeutics (NASDAQ:SAGE)
Storico
Da Ott 2024 a Nov 2024
Grafico Azioni Sage Therapeutics (NASDAQ:SAGE)
Storico
Da Nov 2023 a Nov 2024
