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.

Go deeper with GlobalData

Go deeper with GlobalData

The gold standard of business intelligence.

Find out more

Discover B2B Marketing That Performs

Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

Find out more

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.

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.

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

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.

Clinical Trials Arena Excellence Awards - Nominations Closed

Nominations are now closed for the Clinical Trials Arena Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact

Excellence in Action
Science 37 has won the Research and Development Award in the Site Innovation category for its FDA inspected Direct-to-Patient Site model, delivering nationwide access, faster enrollment and higher retention. Explore how its virtual-first, in home approach is reshaping trial operations and accelerating time to data-driven decisions..

Discover the Impact