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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
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
“Sage is excited to receive feedback from the
Incorporating feedback from the
Support from the
FDAon 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.
FDAin 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
Conference Call Information
Sage will host a conference call and webcast today at
About FDA Breakthrough Therapy Designation
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
SAGE-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.
Various 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
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Paul Cox, 617-299-8377
Maureen L. Suda, 585-355-1134