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Sage Therapeutics: Sage Announces Third Quarter 2015 Financial Results And Recent Pipeline Progress

The following excerpt is from the company's SEC filing.

Expands Pipeline with Selection of Three Next Generation GABA and NMDA Modulators as Development Candidates

Initiated Placebo-Controlled, Proof-of-Concept Trial of SAGE-547 in Severe Postpartum Depression

Cambridge, Mass. November 5, 2015

Sage Therapeutics (NASDAQ: SAGE) today reported business highlights and financial results for the third quarter ended September 30, 2015.

SAGE continues to execute on its mission to be a leading CNS company focusing on life-altering disorders with few or no treatment options, said Jeff Jonas, M.D., Chief Executive Officer of SAGE. Enrollment of our Phase 3 STATUS Trial evaluating SAGE-547 as a treatment for super-refractory status epilepticus is on track, and we have made important recent progress in advancing our earlier stage next generation pipeline. SAGE-217, our first oral New Chemical Entity, is now in Phase 1 clinical development with broad potential across multiple GABA-related disorders. We have initiated our placebo-controlled proof-of-concept study of SAGE-547 in severe postpartum depression. We are also pleased to have selected three new compounds as development candidates, including our first NMDA modulator targeted at two orphan indications where no approved therapies exist. These activities exemplify SAGEs focus on innovation to address treatment of CNS diseases.

GABA Program Updates

SAGE-547 in Super-Refractory Status Epilepticus (SRSE)

: Enrollment is on track for the STATUS Trial, a global, Phase 3, randomized, double-blind, placebo-controlled clinical trial of SAGE-547 for the treatment of patients with SRSE. In August, SAGE reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the STATUS Trial.

Postpartum Depression (PPD):

SAGE has initiated its placebo-controlled proof-of-concept clinical trial of SAGE-547 in patients with PPD. The multi-center, placebo-controlled study is planned to enroll up to 32 patients diagnosed with severe PPD. The Company expects to report top-line results in the first half of 2016. The placebo-controlled study is intended to validate the activity signal observed in an initial open-label study of SAGE-547 as a treatment for PPD.


SAGE is currently dosing subjects in a Phase 1 single ascending dose trial evaluating SAGE-217 in healthy volunteers. Initial top-line results from the study are expected in the first half of 2016. SAGE-217 is a next generation positive allosteric modulator that has been optimized for selectivity of synaptic and extrasynaptic GABA

receptors and for a pharmacokinetic profile allowing once-daily oral dosing. SAGE is developing SAGE-217 for high frequency seizures associated with select neurological disorders, including orphan epilepsies, and other GABA

dysfunction-related disorders, such as essential tremor. In September 2015, SAGE announced positive top-line proof-of-concept data from an exploratory, placebo-controlled study of SAGE-547 in patients with essential tremor.


SAGE is delaying the commencement of Phase 1 clinical development of SAGE-689 to respond to requests from the U.S. Food and Drug Administration for additional non-clinical study data unrelated to toxicology. SAGE-689, a next generation positive allosteric modulator of GABA

receptors, is being developed as an acute parenteral therapy for the treatment of indications where a high degree of anti-seizure activity and sedation are desirable prior to the introduction of general anesthesia, such as status epilepticus.

SAGE-105 and SAGE-324:

SAGE has selected SAGE-105 and SAGE-324 as its next GABA development candidates. Both molecules are differentiated, next generation positive allosteric modulators of GABA

receptors, and are intended to be studied for undisclosed GABA

dysfunction-related disorders.

Publication on SAGE Extrasynaptic-Selective GABA


In August, SAGE scientists and collaborators published an


The Journal of Neuroscience Research

describing preclinical data from animal studies of a next generation extrasynaptic-selective GABA

positive allosteric modulator, SGE-872, suggesting a potential novel therapeutic approach to treat disorders associated with GABA

-related dysfunction.

NMDA Program Updates


SAGE announced today the selection of SAGE-718 as its first NMDA development candidate planned to enter IND-enabling studies. SAGE-718 is...