Sage Therapeutics Reports Topline Results from Pivotal Phase 3 MOUNTAIN Study of SAGE-217 in Major Depressive Disorder
Sage Therapeutics (NASDAQ: SAGE), a biopharmaceutical company developing novel therapies for people with debilitating brain disorders, today reported topline results from the pivotal Phase 3 MOUNTAIN Study evaluating the effect of SAGE-217 on depressive symptoms in adults with major depressive disorder (MDD). The MOUNTAIN Study did not meet its primary endpoint of a statistically significant reduction from baseline compared to placebo in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score at Day 15. SAGE-217 30 mg, given once-daily as an oral treatment, was associated with a mean reduction of 12.6 in HAM-D total score compared to 11.2 for placebo (p=0.115). Patients in the SAGE-217 30 mg group achieved statistically significant reductions in the HAM-D total score at Days 3, 8 and 12 (p<0.018 for each timepoint). The SAGE-217 development program includes five other pivotal studies, two of which have reported positive data, one in MDD and one in postpartum depression (PPD), and three of which are ongoing.
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Post-hoc analysis revealed that in the MOUNTAIN Study, approximately 9% of patients in the SAGE-217 30 mg group had no measurable drug concentration, consistent with non-compliance in taking SAGE-217. Excluding these patients from the primary analysis set (SAGE-217 30 mg vs. placebo) resulted in statistical significance at all timepoints through, and including, Day 15 (p<0.048).
The study enrolled more patients with an overall distribution of milder severity of symptoms than previous studies of SAGE-217. When including only patients with a HAM-D>24 (n=124 for SAGE-217 30 mg), a post-hoc analysis demonstrated statistical significance at all timepoints through, and including, Day 15 (p<0.032). Analyses utilizing a HAM-D cutoff of 25 or 26 were also statistically significant.
SAGE-217 was generally well-tolerated and showed a similar safety profile as seen in earlier studies. Overall reports of adverse events (AEs) during the 14-day treatment period and 28-day follow-up were similar between SAGE-217 and placebo (30 mg 54.2%, 20 mg 50.0%, placebo 48.9%). The most common AEs (≥5%) in either SAGE-217 group were headache, dizziness, somnolence, fatigue, diarrhea, sedation and nausea.