US-based biopharmaceutical company Sage Therapeutics has reported positive top-line results of its Phase II clinical trial of SAGE-547 to treat severe postpartum depression (PPD).
SAGE-547 is an allosteric modulator of both synaptic and extra-synaptic GABAA receptors, developed to treat severe PPD.
The multi-centre, placebo-controlled, double-blind, randomised trial enrolled 32 women who had developed severe depression either in the third trimester or within four weeks of childbirth.
In the trial, patients were randomised at a 1:1 ratio to either SAGE-547 or placebo and were treated with blinded IV inpatient therapy.
The trial achieved its primary endpoint, which was a minimisation of the effects of the disease compared to placebo.
UNC Center for Women’s Mood Disorders UNC perinatal psychiatry programme associate professor and director and PPD-202 trial principal investigator Samantha Meltzer-Brody said: “This is potentially one of the most important clinical findings in the pharmacologic treatment of postpartum depression to date.
“The rapid onset of action of this drug observed in the trial is unlike anything else available in the field to date.
“The data show the potential of the drug to provide relief from the debilitating symptoms of PPD, and to markedly decrease suffering in women who are severely affected.”
The trial also met its secondary endpoint with a difference in the Montgomery–Åsberg Depression Rating Scale (MADRS) after 24 hours and was consistent for 30 days.
SAGE-547 was also well tolerated across the trial with no reported adverse events or discontinuations.
The company has also commenced an expansion of this Phase II clinical programme to determine optimal dosing of SAGE-547 in PPD.