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Sage Therapeutics and Biogen expect to apply to the FDA in 2022.
Zuranolone resulted in a rapid and statistically significant reduction in depressive symptoms, according to new results from the CORAL study.
Sage Therapeutics and Biogen announced the drug met the primary and secondary endpoints in reducing depressive at day 3 and over a two-week treatment period testing zuranolone 50 mg.
In the CORAL study, the investigators compared the combination of zuranolone 50 mg co-initiated with an active standard of care antidepressant to a standard of care antidepressant co-initiated with placebo in patients with major depressive disorder (MDD).
The reduction was demonstrated at the first measured time point with the study drug co-initiated with an open-label standard of care antidepressant as assessed by change from baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17).
Zuranolone 50 mg also showed a statistically significant improvement compared to antidepressant co-initiated with placebo in depressive symptoms over the two-week treatment period.
There was a mean change from baseline in HAMD-17 total score of -8.9 ± 0.39 (n = 210) at day 3 for patients in the study drug cohort, compared to -7.0 ± 0.38 (n = 215) mean change from baseline in patients in the placebo arm.
Over the two-week period, the investigators measured the treatment effect at scheduled visits for day 3, 8, 12, and 15.
The mean change for patients in the zuranolone group was -11.7 ±0.40 (n = 210) compared with -10.1 ±0.39 (n = 215) for the placebo portion of the study.
There was also a statistically significant reduction in HAMD-17 scores in the zuranolone group compared to the antidepressant arm at day 8 and 12. However, zuranolone showed numerical superiority at day 15 and equivalence at day 42.
The investigators also looked at a subgroup of patients (n = 218) with a HAM-A total score of at least 20 at baseline and found zuranolone was nominally statically to placebo in reducing depressive symptoms as measured by the primary endpoint (-9.3 compared to -6.0; HAMD-17 total score change from baseline), as well as key secondary endpoints (-11.7 compared to -9.4; HAMD-17 total score change from baseline).
For safety, zuranolone was generally well-tolerated, with no new safety concerns identified, with the majority of treatment emergent adverse events deemed to be mild or moderate in severity.This is consistent with previous data from the LANDSCAPE program.
The most common adverse events were somnolence (18.4%), dizziness (13.2%) and headache (11.8%) in the treatment group.
The new findings are consistent with previous results showing the benefit of zuranolone in patients with MDD with elevated anxiety across the LANDSCAPE program.
The CORAL study marks 6 positive clinical trials and the company plans to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) in 2022.
“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,” said Priya Singhal, MD, MPH, Head of Global Safety and Regulatory Sciences and Interim Head of R&D at Biogen, 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.”