Sage Therapeutics(NASDAQ:SAGE), a biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, reported top-line results from the Phase 3 ROBIN Study. This study evaluated the effect of SAGE-217 30 mg on depressive symptoms in women with postpartum depression (PPD). After two weeks of outpatient treatment, patients treated with SAGE-217 had a statistically significant improvement of 17.8 points in the Hamilton Rating Scale for Depression (HAMD-17) score, compared to 13.6 for placebo (primary endpoint, p=0.0029), with statistically significant reductions in HAMD-17 compared to placebo maintained through the end of the four-week follow-up. Remission was achieved in 45% of patients treated with SAGE-217 for two weeks as measured by the HAMD-17 compared with 23% of patients receiving placebo (p=0.0122). Results from secondary endpoints were statistically significant and consistent with the primary endpoint (see also Sage Therapeutics).
SAGE-217 was generally well-tolerated with a safety profile consistent with that seen in earlier SAGE-217 trials. Overall reports of AEs were similar between SAGE-217 (58%) and placebo (51%). Two subjects experienced serious adverse events (SAEs), one subject in each group.
“These are strong and consistent data demonstrating a rapid, stable, and clinically meaningful improvement in PPD depressive symptoms in the SAGE-217 treatment group compared to placebo,” said Jeff Jonas, M.D., chief executive officer of Sage. “This is our fifth consecutive positive study in mood disorders with our investigational medicines that utilize our innovative approach to GABA receptor modulation. Data from the ROBIN Study, along with earlier data from our studies with ZULRESSO in PPD and SAGE-217 in major depressive disorder, all point to the promise that our approach may hold – not only in changing the way PPD and MDD are treated, but also in potentially improving the lives of patients suffering from these mood disorders. The team at Sage has shown what rethinking CNS really means.”
The ROBIN Study is part of a pivotal program studying SAGE-217 as a short-course oral treatment for PPD and major depressive disorder. Summary of Top-line SAGE-217 Phase 3 PPD Trial Results Sage’s Phase 3 ROBIN Study evaluated the efficacy, safety and pharmacokinetics of SAGE-217 in 151 adult female patients diagnosed with severe PPD (HAMD-17 =26). Effect on Postpartum Depressive Symptoms: Statistically significant differences in the reduction in HAMD-17 total score of SAGE-217 versus placebo were first observed on Day 3 (-12.5 vs. -9.8; p=0.0255) and the effect was maintained at each timepoint through two weeks of treatment (-17.8 vs. -13.6; p=0.0029), the primary endpoint of the study. The effect was maintained through the four-week follow-up (-19.2 vs. -15.1; p=0.0027).
After two weeks of treatment with SAGE-217, 45% of patients achieved remission (HAMD-17 =7) compared with 23% of patients who received placebo (p=0.0122); at the end of the four-week follow-up, 53% of patients receiving SAGE-217 achieved remission compared with 30% of patients who received placebo (p=0.0102).
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