Clinical-stage biopharmaceutical company Sage Therapeutics has reported positive top-line results from the Phase II clinical trial of orally administered SAGE-217 to treat patients with major depressive disorder (MDD).
SAGE-217 is a positive allosteric modulator optimised for selectivity to synaptic and extrasynaptic GABA receptors and a pharmacokinetic profile ideal for daily oral dosing.
The two-part Phase II trial is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of SAGE-217 in moderate-to-severe MDD patients.
Part A of the trial was an open-label study assessing SAGE-217 in 13 patients, while the randomised, double-blind, parallel-group, placebo-controlled Part B will assess SAGE-217 as a treatment for MDD.
MDD is a mood disorder characterised by depressive symptoms such as a negative mood or a loss of interest or pleasure in daily activities continuously for at least two weeks, along with impaired social, occupational, educational or other important functioning.
Throughout the primary endpoint of the trial, which evaluated safety and tolerability, it was found that the drug was well-tolerated without any serious adverse events or discontinuations.
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The data also indicated a positive outcome for the effect of SAGE-217 on the Hamilton Rating Scale for Depression (HAM-D) total score, which is used to examine recovery from depression.
The secondary objective to evaluate the effect of SAGE-217 compared to baseline after two weeks of once-daily treatment as measured by the HAM-D total score was found to be encouraging.
In a single and multiple ascending dose Phase I clinical programme, SAGE-217 showed consistency with the predicted pharmacokinetic and pharmacologic profile.