Sage, Biogen announce late-stage trial for depression therapy met key goals
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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 Â± 0.39 (n=210) for HAMD-17 from baseline in zuranolone/ADT arm compared to the -7.0 Â± 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 15 of the study over the 2-week treatment period. The mean change over the period for zuranolone/ADT arm was -11.7 Â±0.40 (n=210) compared to -10.1 Â±0.39 (n=215) in ADT/ placebo arm.
Other secondary endpoints comparing the zuranolone/ADT arm against the ADT arm indicated a statistically significant reduction in the HAMD-17 score at Days 8 and 12, while Day 15 demonstrated a numerical superiority and Day 42 showed equivalence, according to the data.
In terms of the safety profile, a majority of trial participants experienced mild or moderate treatment emergent adverse events (TEAEs) in line with previous data on the LANDSCAPE program, which includes five studies for the therapy in MDD.
In December, Biogen (BIIB) and Sage (SAGE) announced new data from two studies of the program.