At the Day 3 primary endpoint, zuranolone 50 mg co-initiated with a standard of care antidepressant showed a statistically significant reduction in depressive symptoms.
Biogen and Sage Therapeutics announced that the CORAL phase 3 study for individuals with major depressive disorder (MDD) met the trial objectives, demonstrating a rapid and statistically significant reduction in depressive symptoms at day 3 and over the 2-week treatment period, meeting the primary and key secondary endpoints.
The significance was demonstrated at the first measured time point at day 3, with zuranolone 50 mg co-initiated with an open-label standard-of-care antidepressant as assessed by a change from the baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17).
The CORAL study also met its key secondary endpoint, with zuranolone co-initiated with a standard-of-care antidepressant demonstrating a statistically significant improvement in depressive symptoms compared with an antidepressant co-initiated with a placebo over a 2-week treatment period.
Additionally, zuranolone was generally well-tolerated, and no new safety signals were identified. In meeting pre-defined objectives, the CORAL study supported the potential of zuranolone when co-initiated with standard of care to accelerate the benefit of depression treatment compared with treatment with antidepressants alone.
The trial results showed a mean change from the baseline in HAMD-17 total score of -8.9 ± 0.39 at day 3 for individuals in the zuranolone arm compared with -7.0 ± 0.38 in the placebo arm.
Furthermore, the key secondary endpoint measured the treatment effects over the 2-week treatment period at scheduled visits and were measured using the equal weighted means for days 3, 8, 12, and 15.
For the secondary endpoint, the mean change over the treatment period for individuals in the zuranolone arm was -11.7 ±0.40 compared with -10.1 ±0.39 for the placebo arm.
Additionally, other secondary endpoints demonstrated statistically significant reductions in HAMD-17 for the zuranolone arm compared with the antidepressant arm at days 8 and 12, while day 15 demonstrated numerical superiority, and day 43 showed equivalence.
Based on the findings that suggested a benefit of zuranolone for individuals with elevated anxiety and MDD across the LANDSCAPE program, the CORAL study examined this population with zuranolone co-initiated with an antidepressant.
The results showed that this arm was nominally statistically significant to ADT with the placebo in reducing depressive symptoms as measured by the primary and key secondary endpoints. Additionally, this demonstrated the potential to address the unmet needs for this population, especially because they have been historically less responsive to chronically administered antidepressants.
“These positive results from the CORAL study indicate that zuranolone co-initiated with standard of care may offer more rapid relief from depressive symptoms than current standard of care taken alone,” Priya Singhal, MD, MPH, head of global safety and regulatory sciences and interim head of research and development at Biogen, said in a statement. “Based on the collective results observed across the LANDSCAPE clinical development program, we believe that zuranolone has the potential to offer a new clinically meaningful treatment option for people with major depressive disorder.”.
Most individuals in the study experienced treatment-emergent adverse events (AEs) that were mild or moderate in severity and remained consistent with data from the LANDSCAPE program.
Common AEs that occurred in individuals in the zuranolone arm were dizziness, headaches, and somnolence.
The CORAL study built on data from the LANDSCAPE clinical program.
Sage Therapeutics and Biogen announce the phase 3 CORAL study met its primary and key secondary endpoints - comparing zuranolone 50 mg co-initiated with standard of care antidepressant vs. standard of care co-initiated with placebo in people with MDD. Biogen. News release. February 16, 2022. Accessed February 17, 2022. http://media.biogen.com/news-releases/news-release-details/sage-therapeutics-and-biogen-announce-phase-3-coral-study-met