Sage wants its depression drug ‘to be first-line every time’

And that means taking a high-risk, high-reward approach to clinical development.

Sage Therapeutics’ oral treatment, SAGE-217, has already established efficacy in postpartum depression and is in the midst of a Phase 3 study in major depressive disorder. Next, the Cambridge, Mass.-based company plans to start a Phase 3 study in treatment-resistant depression before the end of the year.

The risk is two-fold: Treatment-resistant depression has long been a difficult target for novel medicines, and Sage’s supporting evidence for taking 217 to Phase 3 comes from retrospective data, not a custom-built trial. But to Sage CEO Jeff Jonas, it was an easy choice.

“I have a vision for SAGE-217, which as we place it into the clinical marketplace, we really want it to be first-line every time,” Jonas said. “To do that, we need to have treatment-resistant depression.”

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