SAGE Therapeutics Inc(NASDAQ: SAGE) stock is at its all-time high levels, delivering over 73.2% in one single trading session post the positive study results. With today’s rally, the stock performance more than doubled this year (+211.73% in this year to date as of 10:33AM EST; Source: Google finance) delivering outstanding returns to its shareholders.
The group a positive top-line data from the Phase 2, double-blind, placebo-controlled clinical trial of SAGE-217 in the treatment of 89 adult patients with moderate to severe major depressive disorder (MDD). The study showed statistically major improvements in the HAM-D against placebo by the morning post the first dose through Week 4 and the effects of SAGE-217 remained numerically greater than placebo through the end of follow-up at Week 6. SAGE-217 was generally well-tolerated with no serious or severe adverse events.
These milestone shows solid potential of SAGE-217 in treating MDD as well as other mood-related disorders that the group might pursue. The group tapped this space where innovation has been less in the discovery and development of treatments for depression in the last two decades. Phase 3 data read-out evaluating brexanolone for treating postpartum depression, shows pipeline of proprietary GABAA modulators which might hurt 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 while the group would be working with the FDA to determine the next steps in the potential development of SAGE-217.
The successful development of 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. If the results from this trial are replicated in Phase 3 trials, SAGE-217 might meet the needs of patients with MDD for a once-daily oral treatment that potentially provides a rapid, well-tolerated and durable response with a high rate of remission.