Exhibit 99.2
Sage Therapeutics AnnouncesSAGE-217 Meets Primary and Secondary
Endpoints in Phase 3 Clinical Trial in Postpartum Depression
– Statistically significant reduction observed in depressive symptoms compared to placebo in
women with postpartum depression (PPD) –
– Well-tolerated with rapid onset of statistically significant effect (Day 3) through two weeks and
maintained for four weeks after treatment –
CAMBRIDGE, Mass. Jan. 7, 2019 – Sage Therapeutics (NASDAQ: SAGE), a biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today reported top-line results from the Phase 3 ROBIN Study. This study evaluated the effect ofSAGE-217 30 mg on depressive symptoms in women with postpartum depression (PPD). After two weeks of outpatient treatment, patients treated withSAGE-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 inHAMD-17 compared to placebo maintained through the end of the four-weekfollow-up. Remission was achieved in 45% of patients treated withSAGE-217 for two weeks as measured by theHAMD-17 compared with 23% of patients receiving placebo (p=0.0122). Results from secondary endpoints were statistically significant and consistent with the primary endpoint.
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 theSAGE-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 andSAGE-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 studyingSAGE-217 as a short-course oral treatment for PPD and major depressive disorder.
Summary ofTop-lineSAGE-217 Phase 3 PPD Trial Results
Sage’s Phase 3 ROBIN Study evaluated the efficacy, safety and pharmacokinetics ofSAGE-217 in 151 adult female patients diagnosed with severe PPD(HAMD-17³26).
Effect on Postpartum Depressive Symptoms:
| • | | Statistically significant differences in the reduction inHAMD-17 total score ofSAGE-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-weekfollow-up(-19.2 vs.-15.1; p=0.0027). |
| • | | After two weeks of treatment withSAGE-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-weekfollow-up, 53% of patients receivingSAGE-217 achieved remission compared with 30% of patients who received placebo (p=0.0102). |