SAGE Therapeutics Inc (NASDAQ:SAGE) shares were up 37.33% to $46.21 on Tuesday when it announced positive top-line results in the Phase 2 clinical trial for SAGE-547, which is used in the treatment of postpartum depression (PPD). The company has a market cap of $1.47 billion at 32.06 million shares outstanding. Shares have been trading in a 52-week range of $26.28 to $77.48.
The unmet need in the PPD patient population cannot be overstated. 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, M.D., CEO of SAGE Therapeutics.
The trial results showed that SAGE-547 met the primary endpoint of a statistically significant reduction in the Hamilton Rating Scale for Depression or HAM-D, which is a questionnaire is used by mental health professionals to assess the level of depression in a patient.
In addition, data also showed that 70% of the patients involved in the study ere in remission from their depression at the 60-hour mark, which was the primary endpoint of the trial. This compares favorably to the 10% rate seen in the placebo group. Also, the effect also appears to be long-lasting as evidenced in follow-up visits.
Doctors have acknowledged that this might be one of the most important clinical findings in the treatment of PPD to date. Jonas added that this opens the possibility of using their other product pipeline candidates for the treatment of other neurological disorders, as well as mood and affective disorders.
SAGE Therapeutics is a clinical-stage biopharmaceutical company that is s engaged in developing and commercializing medicines to treat central nervous system disorders. Its lead product formulation is SAGE-547, which is an intravenous formulation of allopregnanolone, a neurosteroid that acts as a synaptic and extrasynaptic modulator of the GABAA receptor.
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