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.

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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.

"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."

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.

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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.