SAGE Therapeutics Inc (NASDAQ:SAGE) seems to have achieved a breakthrough in a mid-stage study of a drug for major depressive disorder (MDD). The clinical-stage biopharmaceutical company presented positive results from its Phase 2 clinical trial of orally-administered SAGE-217. The treatment, which was confirmed to be generally safe and well-tolerated, depicted a reduction in depressive symptoms.
The study was primarily designed to evaluate the safety and tolerability of the drug. There were no notable serious adverse events. The postpartum depression medication, which is currently in a Phase 3 study, had an incredible response compared to placebo in an earlier small trial in July. With the positive results so far, it is likely to become the first FDA-endorsed treatment for postpartum depression.
Chief Medical Officer of Sage, which was launched in October 2011, Steve Kanes says, “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 study met our internal criteria for achieving a positive signal: Sage CEO Jeff Jonas says
The strong signal achieved from the study was a significant milestone for Sage according to Jonas. The results gave an additional support into exploring the double-blind placebo-controlled part of the Phase 2 trial. They were also a platform that gave a green light into future investment. Who knows, the company may consider plunging into larger clinical programs. Apparently, the results from SAGE-547 were equally positive.
The company will soon engage in a randomized, double-blind Part B phase of the trial to evaluate SAGE-217 as a treatment for MDD.
Let’s learn about major depression disorder (MDD)
It is a serious mood disorder that affects close to 16 million people in the U.S. Depressed moods, loss of interest or pleasure are some of the common symptoms that patients will display. There is a notable increase in the use of antidepressants to suppress these symptoms but again there is also the need for other enhanced therapies. In any case, the likes of Sage Therapeutics have expressed their commitment to transforming the lives of patients. Meanwhile, Sage Therapeutics’ stock closed at $52.99 witnessing an increase of $5.57 or 11.75%.