Sage Therapeutics to Provide Pipeline Update at J.P. Morgan Healthcare Conference & Outline Key 2018 Initiatives to Support P...
January 08 2018 - 7:00AM
Business Wire
– Company evolving, as planned, to be a
leading, innovative CNS company –
– 2018 strategy focuses on continued R&D
innovation, pipeline expansion and commercialization plans for new
classes of CNS therapeutics –
Sage Therapeutics (NASDAQ: SAGE), a clinical-stage
biopharmaceutical company developing novel medicines to treat
life-altering central nervous system (CNS) disorders, today
announced that in a corporate presentation at the 36th Annual J.P.
Morgan Healthcare Conference in San Francisco, the Company’s Chief
Executive Officer, Jeff Jonas, M.D., will discuss several
components of the Company’s strategy to build the business for the
long term by assembling the capabilities to fully develop and
commercialize important medicines. His remarks will highlight three
key areas of focus in the pursuit of new classes of CNS therapies:
impacting novel, fundamental brain mechanisms; addressing treatment
gaps with differentiated therapies; and discovering a potentially
groundbreaking approach to depressive disorders.
“The lack of adequate treatments for CNS disorders is creating a
global public health crisis due to limited innovation in
neuroscience research and development – until now,” said Dr. Jonas.
“Sage is taking on this challenge with a deliberate, planned
approach. By thinking differently about CNS drug development, we
are originating differentiated medicines with the potential to
exceed expectations, customizing the playbook of commercialization,
and disrupting conventional wisdom by creating a potential new
methodology of care. In 2018, we expect to build on our track
record of success, with the potential to create significant value
by maximizing patient benefit.”
Dr. Jonas will provide additional detail on the following
development programs:
BrexanoloneSage is currently focused on launch readiness
and building commercial infrastructure to ensure successful
commercial execution, if Sage’s proprietary formulation brexanolone
is approved to address postpartum depression (PPD), a common
biological complication of childbirth.
- Filing of New Drug Application (NDA)
planned in 1H 2018
- Buildout of commercial supply chain
activities on track for launch
- Buildout of commercial infrastructure
underway in anticipation of potential 1H 2019 launch
SAGE-217 and SAGE-324Sage's novel, oral, next-generation
positive allosteric modulators of synaptic and extra-synaptic GABAA
receptors.
SAGE-217
- Major Depressive Disorder (MDD):
Initiation of additional clinical studies expected in 2018
- Postpartum Depression: Increased
Phase 2 trial size in PPD with anticipated data readout in 2Q 2018
- Positive results from SAGE-217 Phase 2
trial in MDD and positive Phase 3 results with brexanolone in PPD
support maximizing utility of ongoing Phase 2 trial for overall
depression development program
- Bipolar Depression: Initiation
of development program planned for 2018
- Parkinson’s Disease: Initiation
of placebo-controlled Phase 2b study planned for 2018
- Insomnia: Results from
exploratory Phase 1 placebo-controlled study expected in 1Q 2018;
results to inform potential development path
- Essential Tremor: Completed Part
C of exploratory Phase 2 trial in essential tremor
- Open-label design initiated to study
higher doses and extended dosing in 18 patients
- Improved tremor symptoms, as assessed
by the Kinesia Upper Limb Combined Score, by 16% on Day 15
following two weeks of dosing. Administration of SAGE-217 was
generally well-tolerated
- The most common adverse events were
somnolence, dizziness, and sedation. There were no serious adverse
events reported in the study
- Reductions in kinetic tremor measures
of up to 21% at 40mg suggest twice-daily dosing may be preferable
for this indication
- Planned development efforts in
essential tremor to be moved from SAGE-217 to SAGE-324 based on
respective compound profiles and anticipated twice-daily dosing
requirements for essential tremor
SAGE-324
- Essential Tremor/Epileptiform
Disorders: Continuation of IND-enabling studies; initiation of
Phase 1 study anticipated in 1H 2018
- Plans to explore SAGE-324 in essential
tremor based on positive exploratory placebo-controlled clinical
trial with SAGE-547 and open-label essential tremor studies with
SAGE-217
GABA Discovery Programs
- Evaluating a series of novel GABAA
receptor modulators in pre-clinical development, including
SAGE-689, SAGE-105, and others
NMDA ProgramsSage’s novel, oral, first-in-class
oxysterol-based positive allosteric modulators of the NMDA
receptor.
The Company recently selected SAGE-904 as its second NMDA
receptor positive allosteric modulator product candidate for
development. Positive modulation of NMDA receptors may have
potential in the treatment of a range of neurological disorders
associated with a variety of cognitive, neurological and behavioral
symptoms.
SAGE-718
- Initiation of Phase 1 multiple
ascending dose study anticipated in 1H 2018
- Announcement of clinical development
strategy, including lead indications, planned for 2018
SAGE-904
- Differentiated pharmacologic and
pharmacokinetic profile from SAGE-718
- Recently initiated IND-enabling
studies
2017 Year-End Cash and GuidanceSage ended 2017 with
approximately $518 million of cash, cash equivalents and marketable
securities, including $325.7 million in net proceeds from a public
offering completed in November 2017. Based on its current operating
plans, Sage expects that its operating expenses will increase year
over year in 2018 to support continued pipeline advancement and
potential product commercialization of brexanolone in PPD. Sage
expects to provide specific 2018 financial guidance in its fourth
quarter and full year 2017 financial results announcement in
February 2018.
Webcast Information for J.P. Morgan PresentationSage is
scheduled to present on Tuesday, January 9, 2018 at 11:30 a.m.
Pacific Time (2:30 p.m. Eastern Time), followed by a Q&A
session. A live webcast of the presentation and Q&A session can
be accessed on the investor page of Sage's website at
investor.sagerx.com. A replay of the webcast will be available on
Sage’s website approximately two hours after the completion of the
event and will be archived for up to 30 days.
About Sage TherapeuticsSage Therapeutics is a
clinical-stage biopharmaceutical company committed to developing
novel medicines to transform the lives of patients with
life-altering central nervous system (CNS) disorders. Sage has a
portfolio of novel product candidates targeting critical CNS
receptor systems, GABA and NMDA. Sage's lead program, a proprietary
IV formulation of brexanolone (SAGE-547), has completed two Phase 3
clinical trials in postpartum depression. Sage is developing its
next generation modulators, including SAGE-217 and SAGE-718, in
various CNS disorders. For more information, please
visit www.sagerx.com.
Forward-Looking StatementsVarious statements in this
release concern Sage's future expectations, plans and prospects,
including without limitation: our expectations regarding the timing
of a potential NDA filing and launch of our proprietary formulation
of brexanolone in PPD, and the expected build of commercial
infrastructure and supply chain; our statements regarding plans for
further development of our product candidates and related
activities and our view of the potential for successful
development; our views as to the opportunity represented by Sage’s
portfolio and business, and the potential for value creation; and
our expectations with respect to future use of cash. 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
clinical and non-clinical data we have generated with our
proprietary formulation of brexanolone to date may be determined by
regulatory authorities, despite prior advice, to be insufficient to
file for or gain regulatory approval to launch and commercialize
our product in PPD and regulatory authorities may determine that
additional trials or data are necessary in order to file for or
obtain approval; regulatory authorities may find fault with the
data generated at particular clinical site or sites or with the
activities of our trial monitor or may disagree with our analyses
of the results of our trials or identify issues with our
manufacturing or quality systems, and any such findings or issues
could require additional data or analyses or changes to our systems
that could delay or prevent us from gaining approval of
brexanolone; we may encounter unexpected safety or tolerability
issues with brexanolone, SAGE-217 or any of our other product
candidates in ongoing or future development; we may not be able to
successfully demonstrate the efficacy and safety of SAGE-217 or any
of our other product candidates at each stage of development;
success in early stage clinical trials may not be repeated or
observed in ongoing or future studies of SAGE-217 or any of our
other product candidates; ongoing and future clinical results may
not support further development or be sufficient to gain regulatory
approval to market SAGE-217 or any of our other product candidates;
we may decide that a development pathway for one of our product
candidates in one or more indications is no longer feasible or
advisable or that the unmet need no longer exists; 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 enrollment in ongoing clinical
trials; the internal and external costs required for our
activities, and to build our organization in connection with such
activities, and the resulting use of cash, may be higher than
expected, or we may conduct additional clinical trials or
pre-clinical studies, or engage in new activities, requiring
additional expenditures and using cash more quickly than
anticipated; and we may encounter technical and other unexpected
hurdles in the development and manufacture of our product
candidates; 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. We explicitly disclaim any obligation to update
any forward-looking statements.
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version on businesswire.com: http://www.businesswire.com/news/home/20180108005777/en/
Sage TherapeuticsInvestor:Paul Cox,
617-299-8377paul.cox@sagerx.comorMedia:Maureen L. Suda,
585-355-1134maureen.suda@sagerx.com
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