Sage Therapeutics Announces Presentation of Encouraging Results from the Phase 2 PARADIGM Study (Part A) of SAGE-718 in Patients with Mild Cognitive Impairment due to Parkinson’s Disease
March 15 2022 - 5:30AM
Business Wire
Data Presented at the AD/PD 2022 Advances in
Science & Therapy International Conference on Alzheimer’s and
Parkinson’s Diseases and Related Neurological Disorders
The PARADIGM 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 due to
Parkinson’s disease
Patients who received SAGE-718 in the study
experienced improvement in performance of cognitive tests of
executive functioning and learning and memory
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 that showed SAGE-718, a
first-in-class, oral, positive allosteric modulator of the NMDA
receptor, was associated with improvements on multiple tests of
executive functioning and learning and memory in patients with mild
cognitive impairment (MCI) due to Parkinson’s disease (PD) in the
open label Phase 2 PARADIGM Study. The PARADIGM Study (Part A) 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 were
presented as a virtual oral presentation at the AD/PD 2022 Advances
in Science & Therapy International Conference on Alzheimer’s
and Parkinson’s Diseases and Related Neurological Disorders taking
place from March 15-20 both in-person in Barcelona, Spain, and
virtually.
“Improving cognitive function is an area of significant unmet
need in the management of Parkinson’s disease as it is estimated
that up to 50 percent of people living with PD are affected by
cognitive changes, including mild cognitive impairment, that can
result in loss of independence for patients,” said Jim Doherty,
Ph.D., Chief Development Officer at Sage. “We are encouraged by
these preliminary data as they support our belief in the potential
of SAGE-718 for the treatment of MCI in patients with PD, and we
look forward to learning more from our multiple, ongoing or planned
placebo-controlled clinical trials in patients with PD and other
brain health disorders.”
In the PARADIGM Study (Part A), a comprehensive battery of tests
was used to assess multiple domains of cognitive performance in
eleven patients receiving SAGE-718 3 mg once daily. Tests included
the Digital Symbol Substitution Test, spatial working memory,
stockings of Cambridge, the 2-Back Test and the Multitasking Test.
SAGE-718 was associated with improved performance at Day 14,
compared to baseline, on tests of executive functioning, and an
emerging signal suggests improved performance on tests of learning
and memory (paired associates, pattern recognition, and verbal
memory). Sustained effects and improving trends were seen out to
Day 28 for assessments completed at the follow-up visit. 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. These data support the further
development of SAGE-718 in PD-MCI, suggesting improved performance
on executive functioning, as well as promising signals on learning
and memory.
SAGE-718 was generally well tolerated in the PARADIGM Study
(Part A); there were no serious adverse events and no treatment
emergent adverse events were determined to be related to
SAGE-718.
About the PARADIGM Study (Part A)
The PARADIGM Study (Part A) was a Phase 2, open-label study with
a primary objective to evaluate the safety, tolerability, and
efficacy of SAGE-718 in patients with MCI due to PD. During the
2-week screening period, patients were assessed for the
prespecified inclusion and exclusion criteria. Eligible patients
were aged 50 to 75 years, had a diagnosis of idiopathic PD and MCI
per the 2015 Movement Disorder Society criteria, and Montreal
Cognitive Assessment or MoCA of 20-25 at screening. After the
1-week baseline period, eligible patients entered a 2-week
treatment period during which they received a 3 mg oral dose of
SAGE-718 once daily. The final period was a 2-week, off-treatment
follow-up period. A 4-week dosing cohort, PARADIGM Part B, is
ongoing.
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 (HD),
Parkinson’s disease (PD) and Alzheimer’s disease (AD). Ongoing and
planned 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 HD
cognitive impairment 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 HD, PD
and AD in 2022. In 2021, SAGE-718 received Fast Track Designation
from the FDA for development of SAGE-718 as a potential treatment
for HD.
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 the findings from the PARADIGM
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 Parkinson’s Disease who are affected by
cognitive changes; 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 PARADIGM Study may not be
repeated in future studies in Parkinson’s Disease cognitive
impairment or in other indications we are studying or 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 Parkinson’s
Disease cognitive impairment 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 Meghan Hindman 215-519-5729
meghan.hindman@sagerx.com
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