Shares of Sage Therapeutics Inc. (SAGE) saw a handy gain on Monday after the company announced a successful mid-stage trial for the treatment of major depressive disorder (MDD). Specifically the company reported encouraging top-line results for SAGE-217, which met the primary endpoint of safety and tolerability.
The trial also examined the effect of SAGE-217 on the Hamilton Rating Scale for Depression (HAM-D) total score, in addition to other secondary measures. Patients in the trial had a mean HAM-D total score of 27.2 at baseline. Data demonstrated a mean reduction from baseline in the HAM-D of 19.9 points at Day 15, with 85% (11 of 13) patients showing at least a 50% reduction of their HAM-D and 62% (8 of 13) of patients achieving remission, as determined by a HAM-D score of 7 or less.
The positive results from this clinical trial, along with the outcomes observed with SAGE-547 in postpartum depression, further validate studying this mechanism as a potential broad therapy for the treatment of mood disorders.
The primary endpoint for the Part A study was to evaluate the safety and tolerability of SAGE-217. The Part B phase of the trial will be a randomized, double-blind, parallel-group, placebo-controlled study evaluating SAGE-217 as a treatment for MDD.
Jeff Jonas, M.D., CEO of Sage, commented:
Understanding the caveats associated with open-label data, we are highly encouraged by the strong signal we achieved in this study, which met our internal criteria for achieving a positive signal and thus supported our plan to proceed to the double-blind, placebo-controlled part of the Phase 2 trial. These initial results in MDD were achieved utilizing our data-driven approach to CNS drug development – employing efficient human proof-of-concept studies to both uncover activity signals and help understand future trial methodology, before investing in larger clinical programs.
Shares of Sage were trading up 13% at $53.57 on Monday, with a consensus analyst price target of $75.27 and a 52-week trading range of $26.28 to $56.45.