Shares of Sage Therapeutics Inc. (NASDAQ: SAGE) saw an incredible gain on Thursday after the firm announced positive top-line results from its midstage trial. Specifically, the firm reported results from its Phase 2 trial of Sage-217 for the treatment of moderate to severe major depressive disorder (MDD).
In the trial, treatment for 14 days with Sage-217 was associated with a statistically significant mean reduction in the Hamilton Rating Scale for Depression (HAM-D) of 17.6 points. This compares to a reduction of 10.7 for placebo.
Statistically significant improvements were observed in the HAM-D compared to placebo by the morning following the first dose through the fourth week, and the effects remained numerically greater than placebo through the end of follow-up in the sixth week.
At Day 15, 64% of patients who received SAGE-217 achieved remission, defined as a score of 7 or less on the HAM-D scale, versus 23% who received placebo. Other secondary endpoints were all similarly highly significant at this time as well.
Sage-217 was generally well-tolerated, with no serious or severe adverse events, although these were similar in the placebo group as well. The most common adverse events in the SAGE-217 group were headache, dizziness, nausea and somnolence. A low rate of discontinuations due to adverse events was reported.
Jeff Jonas M.D., CEO of Sage Therapeutics, commented:
These very encouraging data suggest the potential of SAGE-217 in the treatment of MDD as well as other mood-related disorders that we may pursue. There has been little innovation in the discovery and development of treatments for depression in the last two decades. Coupled with our recent positive Phase 3 data read-out evaluating brexanolone for the treatment of postpartum depression, the findings in this study suggest our pipeline of proprietary GABAA modulators may impact novel and fundamental brain mechanisms, offering potential development opportunities in a variety of indications. The positive activity and safety findings of SAGE-217 in MDD support advancing the program into later stage clinical development and we will work with the FDA to determine next steps in the further development of SAGE-217.
Shares of Sage were last seen up roughly 73% at $159.18, with a consensus analyst price target of $116.07 and a 52-week range of $44.55 to $169.58.