- Cambridge, MA-based Sage Therapeutics said Tuesday its investigational drug for severe postpartum depression substantially eased symptoms in seven out of 10 women, sending its stock soaring nearly 40% despite the tiny size of the study.
- After 60 hours, treatment with the drug led to a 20 point mean reduction in a measure of depression known as HAM-D, a statistically significant result compared to a placebo. Only one out 11 women on the placebo experienced remission from depression after 60 hours.
- The Phase 2 trial was Sage's second study evaluating the drug, known as SAGE-547, and the company plans to continue with an expanded dose-exploration study by the end of the year.
Although a 21-patient study for a depressive disorder which can affect as many as one out of 10 women is quite small, Sage was quick to tout the trial results.
"These data speak for themselves. Given the societal impact of this condition, and the possible identification of a biological basis for treating these women, we are hopeful these data will point to a new understanding of this disorder and the development of effective therapies" said Jeff Jonas, CEO of Sage.
Markets certainly agreed with the bullish view of the drug, with stocks jumping immediately after markets opened Tuesday.
Women suffering from postpartum depression (PPD) can experience depressive symptoms intense enough to interfere with daily life functions and taking care of their baby. Unlike feelings of stress and anxiety typically felt by women after giving birth, PPD doesn't go away on its own and can last for months if untreated, according to the American Psychological Association.
There are no current treatments specifically designed to treat the disorder.
Sage believes its drug could fill that gap. Some patients began experiencing improvement in symptoms as early as 24 hours beginning administration of the drug, which is delivered intravenously over 60 hours.
Benefit from treatment endured through 30 days, with seven out of 10 women in remission from depression, compared to 2 out of the 11 women on placebo.
Strangely, more adverse events were reported in the placebo arm than in the treatment arm. None of the individuals who received the drug reported psychiatric side effects, but five out of 11 on the placebo did, the company said. Three patients in each group experienced dizziness, sedation, or somnolence.
Although Sage trumpeted its results, the small size of the trial raises concerns about the durability of the drug's positive effect on patients when studied in a larger trial.
Discovering effective treatments has been difficult and the FDA typically requires larger studies to confirm data generated by smaller studies.
Earlier this year for example, two Phase 3 studies of a depression drug developed by Alkermes failed to meet their primary endpoints. Those trials enrolled 429 and 385 patients, respectively (although the drug was aimed at another form of depression, major depressive disorder).
Sage is also developing another drug, tagged SAGE-217, for treatment of PPD.