Sage Announces Pivotal Phase 3 Trial Status for SAGE-217 in Major Depressive Disorder and Postpartum Depression based on FDA Breakthrough Therapy Meeting
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Sage Announces Pivotal Phase 3 Trial Status for SAGE-217 in Major
Depressive Disorder and Postpartum Depression based on FDA Breakthrough
Therapy Meeting
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 Information
Sage 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
(http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Finvestor.sagerx.com%2F&esheet=51820680&newsitemid=20180612005398&lan=en-US&anchor=investor.sagerx.com&index=1&md5=8fbfe5fd66fad0a2b6e87e55c680ce5c)
.
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 Designation
The 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 Disorder
Major 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 Depression
Postpartum 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-217
SAGE-217 is a next generation positive
allosteric modulator that has been optimized for selectivity to synaptic
and extrasynaptic GABA(A) 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 Therapeutics
Sage 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(A )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
(http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.sagerx.com&esheet=51820680&newsitemid=20180612005398&lan=en-US&anchor=www.sagerx.com&index=2&md5=bf9846be8b8beda5a9667b49b0045985) |
