Sage changes primary endpoint in key study months after analysts fret about depression drug's durability
In its quest to deliver a new drug to treat major depressive disorder, Sage Therapeutics recently updated its Phase III study with a change analysts believe gives the biotech a better chance at FDA approval.
Sage altered the primary endpoint in a trial evaluating the program zuranolone as a rapid response therapy on top of SSRIs, execs announced in Tuesday’s earnings call, saying researchers would compare changes from baseline in a depression rating scale after three days. Previously, the biotech had sought to look at the difference in placebo after 15 days.
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