Sage Therapeutics Receives Fast Track Designation for SAGE-718 for the Treatment of Huntington’s Disease
September 15 2021 - 6:30AM
Business Wire
Sage Therapeutics, Inc. (Nasdaq:SAGE), a biopharmaceutical
company committed to developing novel therapies with the potential
to transform the lives of people with debilitating disorders of the
brain, today announced that the U.S. Food and Drug Administration
(FDA) has granted Fast Track Designation to SAGE-718 for
development as a potential treatment for Huntington’s disease (HD).
Fast Track is a process designed to facilitate the development and
review of new treatments for serious conditions with unmet medical
need such as HD.
“HD is an autosomal dominant genetic disorder that impacts the
brain and by nature numerous generations of a family. Cognitive
decline is often one of the earliest signs of the disease and this
decline, in addition to other symptoms, results in a devastating
impact on independence, general functioning, and quality of life.
We believe that improving cognitive function is one of the core
paths to maintaining quality of life in HD and remains an area of
significant unmet medical need,” said Jim Doherty, Ph.D., chief
research officer at Sage Therapeutics. “In studies to date,
treatment with SAGE-718 has been associated with improved cognitive
performance, particularly in the domain of executive functioning.
The FDA Fast Track Designation is an important milestone in the
development of SAGE-718, as it provides opportunities to engage
collaboratively with the FDA to further clinical development and
future regulatory review of SAGE-718 for the treatment of HD.”
About Fast Track Designation Fast Track is a process
designed to facilitate the development, and expedite the review, of
drugs to treat serious conditions and fill an unmet medical need.
Drugs that receive Fast Track designation may be eligible to be the
subject of more frequent communications and meetings with FDA to
review the drug's development plan including the design of the
proposed clinical trials, use of biomarkers and the extent of data
needed for approval. Drugs with Fast Track Designation may also
qualify for priority review to expedite the FDA review process, if
relevant criteria are met.
The purpose is to get important new drugs to the patient
earlier. Fast Track addresses a broad range of serious conditions.
For more information about Fast Track, please visit:
https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm.
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 studies aim to evaluate whether SAGE-718 may
have the potential to improve cognitive symptoms for these
difficult-to-treat disorders. Sage expects to initiate a
placebo-controlled Phase 2 trial with SAGE-718 in early to moderate
HD in late 2021.
About Huntington’s Disease Huntington’s disease (HD) is a
rare, inherited neurodegenerative disease that progresses over
time. Up to 30,000 adults are diagnosed with HD in the U.S. each
year. Symptoms usually appear between ages 30–45, worsen over the
following 15–20 years, and ultimately lead to death. Psychiatric
and cognitive symptoms can severely affect people with HD.
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 expectations regarding the
potential benefit of Fast Track designation; our plans and expected
timelines for development of SAGE-718; our view of the potential
profile and benefit of SAGE-718 and potential indications; our
expectations as to the unmet need in the treatment of Huntington’s
disease; and our other statements as to the potential opportunity
for our programs and 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: Fast
Track designation from the FDA may not lead to a faster or
successful development of SAGE-718 and, even if development is
successful, may not result in a faster or successful regulatory
review process; the FDA may withdraw Fast Track designation at any
time; we may not be successful in our development of SAGE-718 or
any of our other product candidates in any indication we are
currently pursuing or may in the future pursue; success in
non-clinical studies or in earlier clinical trials or at interim
time periods may not be repeated or observed in ongoing or future
studies or in studies in other indications, and ongoing and future
non-clinical and clinical results may not meet their primary or key
secondary endpoints or be sufficient to file for or gain regulatory
approval to market the product without further development work or
may not support further development at all; 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 FDA may not agree that
the design or results of our nonclinical studies and clinical
trials for SAGE-718 or any of our other product candidates, even if
positive, are sufficient to file for or obtain regulatory approval
in the indications that are the focus of our development plans even
if we have had prior discussions with the agency supporting our
approach; other 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; the unmet need for additional treatment options for
Huntington’s disease or any other indications we are studying or
may study in the future with SAGE-718 or any of our other product
candidates may be significantly smaller than we expect; and we may
encounter technical and other unexpected hurdles in the development
and manufacture of SAGE-718 or any of our other product candidates
which may delay our timing or change our plans, increase our costs
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210915005156/en/
Investors Helen Rubinstein 315-382-3979
helen.rubinstein@sagerx.com
Media Maureen L. Suda 617-949-4289
maureen.suda@sagerx.com
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