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news.Sage Therapeutics has unveiled positive top-line results including demonstration of 30-day durability from phase 2 clinical trial of SAGE-547 in severe postpartum depression (PPD).
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The study met its primary endpoint of a significant reduction in in depression symptoms from baseline compared to placebo as measured by the total score in the Hamilton Rating Scale for Depression (HAM-D) at 60 hours (p=0.008).
The company said the statistically significant difference in treatment effect started at hour 24 (p=0.006) and remained in effect at similar magnitude through the 30-day follow-up period (p=0.01).
SAGE-547 was well-tolerated with no severe adverse events reported.
Sage Therapeutics CEO Jeff Jonas said: “These data speak for themselves. The unmet need in the PPD patient population cannot be overstated.
“Given the societal impact of this condition, and the possible identification of a biological basis for treating these women, we are hopeful these data will point to a new understanding of this disorder and the development of effective therapies.”
The company has started an expansion of the phase 2 clinical program to identify optimal dosing of SAGE-547 in PPD.
It includes dose exploration in moderate as well as severe patients. The company expects to start enrollment before the end of the year.
Sage also plans to go ahead with a PPD program involving its oral molecule, SAGE-217, and to seek regulatory input to identify the relevant pathways for developing both medications for this indication.