[Corrected 11:53 a.m. See below.] Sage Therapeutics’ new clinical trial results for postpartum depression may have a far-reaching impact not only on women who suffer from the condition but also on the direction of Sage itself.
The Cambridge, MA-based drug developer said this morning that its therapy succeeded in ending depression in women during a randomized, placebo-controlled Phase 2 clinical trial. The study showed that the therapy, an infused treatment called SAGE-547, resulted in “complete remission” of postpartum depression 60 hours after patients were treated and then for 30 days after the treatment was given. [Corrected initial time measure for treatment.]
But the findings, which come with important caveats about the small trial size, could also prove particularly meaningful for Sage (NASDAQ: SAGE) itself, as it considers how much to focus on postpartum depression, general depression, and other mood disorders such as mania, according to CEO Jeff Jonas (pictured). Sage now has decided to expand its Phase 2 study of SAGE-547, and also is aiming to push an oral version of the treatment, SAGE-217, into a Phase 2 trial. Jonas says that he expects this pill form of the treatment could eventually supplant the infused version.
In a recent interview with Xconomy’s Ben Fidler, Jonas said that positive results could encourage Sage to dive deeper into studying mood disorders—from panic attacks to post-traumatic stress disorder.
“We think we may have the leading pipeline in the industry of molecules that target this particular mechanism,” Jonas said in the recent interview. “It does have big implications for the company strategically, and potentially for the field itself.”
Jonas reiterated the sentiment after the release of the clinical trial results this morning, noting that the company plans to “bolster its pipeline” of treatments in mood disorders that target an neurotransmitter called GABA. The Sage strategy of using ‘547 as a “probe” into a range of disorders has netted two encouraging early-stage results, in postpartum depression and, last year, in a severe form of epilepsy called super refractory status epilepticus (SRSE). But the strategy faces a starker test with the ongoing 140-person Phase 3 trial in SRSE, the first exposure of ‘547 to a larger population. Results are due next year.
It’s not immediately clear how many patients Sage expects to enroll as it expands the Phase 2 postpartum trial. The results released today encompassed 21 patients who had given birth in the six months prior to the start of the trial, and had experienced a major episode of depression that began no earlier than the third trimester and no later than four weeks after having a child.