SAGE - Sage Biogen announce late-stage trial for depression therapy met key goals
Sage (NASDAQ:SAGE) and Biogen (NASDAQ:BIIB) announced that their Phase 3 CORAL study for zuranolone met primary and key secondary endpoints in adults with major depressive disorder (MDD). However, Sage (SAGE) shares are trading ~6% lower in the pre-market on Wednesday. In a 440-subject double-blind, placebo-controlled trial, 50 mg of therapy co-initiated with an open-label standard of care antidepressant (ADT) was compared to a standard of care ADT co-initiated with placebo. The primary endpoint was the Day 3 change in baseline 17-item Hamilton Rating Scale for Depression (HAMD-17) total score, a key measure designed to assess the disease severity. The trial indicated a mean change of -8.9 ± 0.39 (n=210) for HAMD-17 from baseline in zuranolone/ADT arm compared to the -7.0 ± 0.38 (n=215) mean change for the ADT/ placebo arm. As the key secondary endpoint, the treatment effect was measured at all scheduled visits for Days 3, 8, 12, and
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Sage, Biogen announce late-stage trial for depression therapy met key goals