Phase III ROBIN Study of SAGE 217 meets primary endpoints in postpartum depression.- Sage Therapeutics.
Sage Therapeutics reported top-line results from the Phase III ROBIN Study evaluating the effect of SAGE-217 30 mg on depressive symptoms in women with postpartum depression (PPD). After two weeks of outpatient treatment, patients treated with SAGE-217 had a statistically significant improvement of 17.8 points in the Hamilton Rating Scale for Depression (HAMD-17) score, compared to 13.6 for placebo (primary endpoint, p=0.0029), with statistically significant reductions in HAMD-17 compared to placebo maintained through the end of the four-week follow-up.
Remission was achieved in 45% of patients treated with SAGE-217 for two weeks as measured by the HAMD-17 compared with 23% of patients receiving placebo (p=0.0122). Results from secondary endpoints were statistically significant and consistent with the primary endpoint. SAGE-217 was generally well-tolerated with a safety profile consistent with that seen in earlier SAGE-217 trials. Overall reports of AEs were similar between SAGE-217 (58%) and placebo (51%). Two subjects experienced serious adverse events (SAEs), one subject in each group.
Comment: SAGE-217 is a next generation positive allosteric modulator that has been optimized for selectivity to synaptic and extrasynaptic GABAA receptors and a pharmacokinetic profile intended for daily oral dosing. The GABA system is the major inhibitory signaling pathway of the brain and central nervous system (CNS), and contributes significantly to regulating CNS function. SAGE-217 is currently being developed for MDD, PPD and certain other mood disorders.
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