Sage Therapeutics, Biogen See Positive Results for Depression Treatment

By Chris Wack

Sage Therapeutics Inc. and Biogen Inc. said a study in people with major depressive disorder met the trial objectives, demonstrating a rapid and statistically significant reduction in depressive symptoms at day three and over the two-week treatment period, achieving the primary and key secondary endpoints.

The companies said this significance was demonstrated at the first measured time point, Day 3, with zuranolone 50 mg co-initiated with an open-label standard of care antidepressant.

The study also met its key secondary endpoint, with zuranolone co-initiated with a standard of care ADT demonstrating a statistically significant improvement in depressive symptoms compared with ADT co-initiated with placebo, over the two-week treatment period.

Zuranolone was generally well-tolerated, and no new safety signals attributable to zuranolone were identified. In meeting its pre-defined objectives, the study supports the potential of zuranolone, when co-initiated with standard of care, to accelerate the benefit of depression treatment compared with treatment with antidepressants alone.

Sage said that including this most-recent study, zuranolone now has six positive clinical studies, and the company remains on track to start the rolling submission for a New Drug Application in MDD early this year with completion targeted for the second half of 2022.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

February 16, 2022 07:33 ET (12:33 GMT)

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