Expedited SAGE-217 development plan to support
potential NDA submission for MDD and PPD
Previously completed placebo-controlled study
in MDD considered as pivotal; initiation of one additional Phase 3
pivotal trial anticipated in 2H of 2018
Ongoing study in PPD designated as pivotal;
results expected in 4Q 2018
If successfully developed, SAGE-217 has the
potential to be the first durable, rapid-acting, oral, short-course
treatment for MDD and PPD
Company to host conference call today at 8:00
A.M. ET
Sage Therapeutics (NASDAQ: SAGE), a clinical-stage
biopharmaceutical company developing novel medicines to treat
life-altering central nervous system (CNS) disorders, today
announced its expedited development plan for SAGE-217 following a
Breakthrough Therapy meeting with the U.S. Food and Drug
Administration (FDA). This development plan is intended to support
a potential filing for approval of SAGE-217 in the U.S. for the
treatment of major depressive disorder (MDD) and postpartum
depression (PPD).
The expedited development plan for SAGE-217 includes a single
additional placebo-controlled Phase 3 pivotal trial in patients
with MDD and the ongoing placebo-controlled trial in women with
PPD, now designated a pivotal trial. Both clinical trials are
designed to evaluate the novel concept of episodic dosing, or short
course treatment, with SAGE-217 and its effect on the reduction of
depressive symptoms compared to placebo. An open-label study will
evaluate the potential of episodic treatment for recurrent or new
major depressive episodes and provide additional safety data.
Sage plans to initiate the placebo-controlled Phase 3 trial in
MDD during the second half of 2018. Further, Sage anticipates
announcing top-line data from the placebo-controlled pivotal trial
of SAGE-217 in PPD in the fourth quarter of 2018. This expedited
pivotal program is supported by the results of a positive
placebo-controlled trial in patients with MDD announced in December
2017.
“Sage is excited to receive feedback from the FDA that provides
a possible groundbreaking path forward for the development of
SAGE-217 for the treatment of depression,” said Jeff Jonas, M.D.,
chief executive officer of Sage. “In this development program, we
are exploring the potential for patients with MDD to feel well
within days, with just a 2-week course of treatment – similar to
how antibiotics are used today – instead of enduring long-term
chronic treatment. We believe a medicine with rapid onset and
robust response could be truly paradigm shifting. SAGE-217, if
successfully developed and approved, may rewrite the textbook on
how the tens of millions of people suffering from MDD are treated,
ultimately turning depression into a disorder, not an
identity.”
Incorporating feedback from the FDA, the following are the
elements of the expected clinical and regulatory path for the
SAGE-217 development program moving forward:
- Support from the FDA on a path forward
in both MDD and PPD, allowing an expedited development plan.
- Ongoing multi-center, double-blind,
placebo-controlled, randomized clinical trial evaluating two weeks
of 30mg SAGE-217 treatment compared to placebo in 140 patients with
PPD, confirmed as appropriate to support registration for PPD, if
both the MDD and PPD trial are successful, and is now designated a
pivotal clinical trial.
- One additional Phase 3
placebo-controlled efficacy study planned for SAGE-217 in MDD,
evaluating two weeks of 20mg or 30mg SAGE-217 treatment compared to
placebo in 450 patients with MDD, with four weeks of additional
follow-up.
- Support from FDA in exploring the novel
concept of episodic dosing.
- Additional data regarding patient
safety and potential treatment of recurrent or new major depressive
episodes will be acquired through a long-term open-label study
program in which approximately 300 patients will be followed for
six months and 100 patients would be followed for a year after
initial treatment and episodic retreatment as needed.
Sage received Breakthrough Therapy Designation from the FDA for
SAGE-217 in MDD in February 2018. The Breakthrough Therapy
Designation is intended to offer a potentially expedited
development path and review for promising drug candidates, which
includes increased interaction and guidance from the FDA. This
regulatory decision was based primarily on the positive results
from the placebo-controlled trial of SAGE-217 in 89 adult patients
with moderate to severe MDD. In the trial, SAGE-217 met the primary
endpoint with a statistically significant mean reduction in the
Hamilton Rating Scale for Depression (HAM-D) 17-item total score
from baseline at Day 15 in the SAGE-217 group, compared to placebo
(p<0.0001). Statistically significant improvements were observed
in the HAM-D score compared to placebo by the morning following the
first dose through Week 4 and the effects of SAGE-217 remained
numerically greater than placebo through the end of follow-up at
Week 6. SAGE-217 was generally well-tolerated. The most common
adverse events in the SAGE-217 group were headache, dizziness,
nausea, and somnolence.
Conference Call InformationSage will host a conference
call and webcast today at 8:00 A.M. ET to discuss the expedited
development plan for SAGE-217 following a Breakthrough Therapy
meeting with the U.S. Food and Drug Administration (FDA). The live
webcast can be accessed on the investor page of Sage’s website at
investor.sagerx.com. The conference call can be accessed by dialing
866-450-8683 (toll-free domestic) or 281-542-4847 (international)
and use the conference ID 6378326. 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 FDA Breakthrough Therapy DesignationThe FDA's
Breakthrough Therapy Designation is intended to expedite the
development and review of a drug candidate that is planned for use,
alone or in combination with one or more other drugs, to treat a
serious or life-threatening disease or condition when preliminary
clinical evidence indicates that the drug may demonstrate
substantial improvement over existing therapies on one or more
clinically significant endpoints. The benefits of Breakthrough
Therapy Designation include the same benefits as Fast Track
Designation, plus an organizational commitment involving FDA’s
senior managers with more intensive guidance from the FDA.
Breakthrough Therapy Designation does not change the standards for
approval.
About Major Depressive DisorderMajor depressive disorder
(MDD) is a common but serious mood disorder in which patients
exhibit depressive symptoms, such as a depressed mood or a loss of
interest or pleasure in daily activities consistently for at least
a two-week period, and demonstrate impaired social, occupational,
educational or other important functioning. It is estimated that
approximately 16 million people in the U.S. suffer from MDD each
year. While antidepressants are widely used for treatment, large
scale studies have demonstrated the need for additional
therapies.
About Postpartum DepressionPostpartum depression (PPD) is
a distinct and readily identified major depressive disorder that is
the most common medical complication of childbirth, affecting a
subset of women typically commencing in the third trimester of
pregnancy or within the months after giving birth. PPD may have
devastating consequences for a woman and for her family, which may
include significant functional impairment, depressed mood and/or
loss of interest in her newborn, and associated symptoms of
depression such as loss of appetite, difficulty sleeping, motor
challenges, lack of concentration, loss of energy and poor
self-esteem. Suicide is the leading cause of maternal death
following childbirth. In the U.S., estimates of new mothers
identified with PPD each year vary by state from 8 to 20 percent,
with an overall average of 11.5 percent. More than half of these
cases may go undiagnosed without proper screening. There are no
FDA-approved therapies for PPD and there is a high unmet medical
need for improved pharmacological therapy in PPD.
About SAGE-217SAGE-217 is a next generation positive
allosteric modulator that has been optimized for selectivity to
synaptic and extrasynaptic GABAA receptors and a pharmacokinetic
profile intended for daily oral dosing. The GABA system is the
major inhibitory signaling pathway of the brain and CNS, and
contributes significantly to regulating CNS function. SAGE-217 is
currently being developed for MDD and certain other mood and
movement disorders.
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, GABAA and NMDA. Sage's lead program, a
proprietary IV formulation of brexanolone (SAGE-547), has completed
Phase 3 clinical development for postpartum depression and a new
drug application is currently under review with the U.S. Food and
Drug Administration. 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 statements as to the potential
for expedited development of SAGE-217 in MDD and PPD; our
expectations as to the timing of results from the clinical trial of
SAGE-217 in PPD and initiation of a Phase 3 clinical trial of
SAGE-217 in MDD; our expectations regarding the potential
sufficiency of the planned development program, if successful, to
support regulatory filing and approval of SAGE-217 in MDD and PPD;
our views as to the need for additional treatment options in MDD
and the potential of SAGE-217 to represent a potential paradigm
shift in the treatment of MDD; our estimates as to the number of
patients with MDD and PPD; our statements regarding the potential
for expedited development and review as the result of Breakthrough
Therapy Designation; and our statements regarding the potential of
SAGE-217 and Sage's other product candidates. 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: we
may not achieve expedited development or review of SAGE-217 despite
the results of the Breakthrough Therapy meeting; the FDA may
ultimately decide that the design or results of our clinical trials
for SAGE-217 are not sufficient for regulatory approval in MDD, PPD
or any other indication or do not support episodic treatment of MDD
which is the focus of our expedited development plan; we may
encounter delays in enrollment and site initiation that may impact
our ability to meet our expected time-lines; we may not be
successful in our development of SAGE-217 in MDD or PPD or in our
development of any of our product candidates in any indication we
are currently pursuing or may in the future pursue; success in our
non-clinical studies or in earlier stage clinical trials may not be
repeated or observed in ongoing or future studies, and ongoing and
future non-clinical and clinical results, including with respect to
SAGE-217, may not support further development or be sufficient to
gain regulatory approval to market the product; we may encounter
adverse events at any stage of development that negatively impact
further development; the actual size of the MDD and PPD patient
populations may be significantly lower than our estimates and, even
if SAGE-217 is approved, it may only be approved or used to treat a
subset of the relevant patient populations; and we may encounter
technical and other unexpected hurdles in the development and
manufacture of SAGE-217 or any of our other products 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 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/20180612005398/en/
Sage TherapeuticsInvestor Contact:Paul Cox,
617-299-8377paul.cox@sagerx.comorMedia Contact:Maureen L. Suda,
585-355-1134maureen.suda@sagerx.com
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