SAGE Therapeutics Inc. (NASDAQ: SAGE) shares rocketed by as much as 79 percent after it had reported successful results from its mid-stage clinical trial for its depression drug.
SAGE-217, the drug used to treat major depressive disorder (MDD), met all primary endpoints and provided rapid and durable effects throughout the 2-week treatment period and another 4 weeks to follow up afterwards.
In the two weeks for the treatment, SAGE-217 showed significant reductions in the Hamilton Rating Scale for Depression (HAM-D) 17-Item total score from baseline to Day 15 of 17.6 points for SAGE-217, compared to a 10.7 for the placebo. SAGE-217 also showed a 64 percent of patients achieved MDD remission by day 1, compared to the 23 percents who received the placebo.
SAGE-217 was well tolerated, with no serious or severe adverse events; the most common adverse events (AEs) in the SAGE-217 group were headache, dizziness, nausea, and somnolence.
“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,” said Jeff Jonas, chief executive officer of Sage Therapeutics.
“If successfully developed, SAGE-217 has the potential to offer the first truly new mechanism of action in the pharmacologic treatment of depression in more than 20 years,” said Steve Kanes, chief medical officer of Sage Therapeutics.