Full top-line dataset, including 30-day follow-up, expected in July 2016
CAMBRIDGE, MA, USA I May 26, 2016 I Sage Therapeutics, Inc. (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced that enrollment has been completed in its Phase 2 placebo-controlled, proof-of-concept clinical trial of SAGE-547 in women with severe postpartum depression (PPD).
The Company has decided to include 30-day follow-up data in its anticipated announcement of top-line data, and currently expects to report these results in July 2016. Presentation of a more comprehensive dataset from the trial is expected at a future medical meeting.
The Phase 2, proof-of-concept, multi-center, placebo-controlled, double-blind, 1:1 randomization trial is designed to enroll up to 32 female patients diagnosed with severe PPD, characterized by a Hamilton Rating Scale for Depression (HAM-D) score of ≥26 prior to treatment and less than 6 months postpartum. The primary endpoint of the study is the effect of SAGE-547 on the HAM-D score as measured by the change from baseline compared to placebo at 60 hours. Patients are being monitored during a 30-day follow-up period to assess both safety and behavioral outcomes.
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 and NMDA. Sage’s lead program, SAGE-547, is in Phase 3 clinical development for super-refractory status epilepticus, a rare and severe seizure disorder. Sage is developing its next generation modulators, including SAGE-217, SAGE-689 and SAGE-718, with a focus on acute and chronic CNS disorders. For more information, please visit www.sagerx.com.
SOURCE: Sage Therapeutics
Post Views: 17
Full top-line dataset, including 30-day follow-up, expected in July 2016
CAMBRIDGE, MA, USA I May 26, 2016 I Sage Therapeutics, Inc. (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced that enrollment has been completed in its Phase 2 placebo-controlled, proof-of-concept clinical trial of SAGE-547 in women with severe postpartum depression (PPD).
The Company has decided to include 30-day follow-up data in its anticipated announcement of top-line data, and currently expects to report these results in July 2016. Presentation of a more comprehensive dataset from the trial is expected at a future medical meeting.
The Phase 2, proof-of-concept, multi-center, placebo-controlled, double-blind, 1:1 randomization trial is designed to enroll up to 32 female patients diagnosed with severe PPD, characterized by a Hamilton Rating Scale for Depression (HAM-D) score of ≥26 prior to treatment and less than 6 months postpartum. The primary endpoint of the study is the effect of SAGE-547 on the HAM-D score as measured by the change from baseline compared to placebo at 60 hours. Patients are being monitored during a 30-day follow-up period to assess both safety and behavioral outcomes.
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 and NMDA. Sage’s lead program, SAGE-547, is in Phase 3 clinical development for super-refractory status epilepticus, a rare and severe seizure disorder. Sage is developing its next generation modulators, including SAGE-217, SAGE-689 and SAGE-718, with a focus on acute and chronic CNS disorders. For more information, please visit www.sagerx.com.
SOURCE: Sage Therapeutics
Post Views: 17
