- Sage Therapeutics saw its stock climb over 7% Tuesday after announcing the Food and Drug Administration agreed to the Cambridge, MA-based drugmaker's development plan for its postpartum depression (PPD) drug.
- Two current mid-stage trials testing SAGE-547 in moderate and severe PPD will be expanded into registrational Phase 3 studies with only minor modifications, giving Sage a shot at filing a new drug application in 2018.
- Sage had originally planned to enroll just under 100 patients in two Phase 2 studies expanding on a tiny, 21-patient study that read out positive in July. The company didn't disclose how many patients it would add.
Sage's stock soared in July after revealing treatment with SAGE-547 led to a 20-point mean reduction in a measure of PPD known as HAM-D. The statistically significant results buoyed hopes that Sage's treatment could fill the unmet medical need in PPD, which can cause intense depressive symptoms in women following childbirth.
But the tiny sample size — just 10 women received SAGE-547, while 11 received placebo — tempered expectations of how quickly Sage would be able to put together a clinical package sufficient for approval.
Recent discussions with the FDA confirmed the trial design and primary endpoint of Sage's current clinical programs would be acceptable. Both studies measure change from baseline in Hamilton rating scale for depression, or HAMD, scores.
While the company will need to expand enrollment and make some small (unspecified) changes, no further efficacy studies would be required if trial results are positive.
Sage expects top-line data from the two now-registrational studies will read out in the second half of next year (likely on the later end), setting up a filing in 2018.
SAGE-547 is an intravenous treatment designed to correct imbalances of GABAA receptors in the brain. Those receptors have great control over neurotransmission, and have been known to interact with many pharmaceuticals.