Sage Therapeutics rockets on new postpartum depression drug data

Shares of US clinical-stage biotech Sage Therapeutics (Nasdaq: SAGE) surged 51% to pre-market, settling up 42% at $47.70 in early trading, after the company announced positive top-line results from its Phase II clinical trial of its lead candidate SAGE-547 for the treatment of severe postpartum depression (PPD).

SAGE-547 achieved the primary endpoint of a significant reduction in the HAM-D score compared to placebo at 60 hours (p=0.008). This represented a greater than 20 point mean reduction in the depression scores of the SAGE-547 group at the primary endpoint of 60 hours through trial completion with a greater than 12 point difference from placebo.

The statistically significant difference in treatment effect began at 24 hours, (p=0.006) with an effect that was maintained at similar magnitude through to the 30-day follow-up (p=0.01). Remission from depression, as determined by a HAM-D ≤7, measured at 60 hours, was seen in seven of 10 of the SAGE-547 group compared with 1 of 11 in the placebo group (p=0.008). Similarly, at 30 days, seven of 10 of the SAGE-547 group and two of 11 in the placebo group were in remission (p=0.03). SAGE-547 was found to be generally well-tolerated with no serious adverse events reported during the treatment and follow-up periods. There are no approved therapies specifically for PPD and therapeutic options in severe PPD are limited.