Curio Digital Therapeutics, Inc. (“Curio”), today announced positive data from the Supporting Maternal Mental Health and Emotional Regulation (SuMMER) trial. SuMMER (NCT05958095), a study executed by HITLAB, a renowned healthcare innovation and research organization, is a randomized clinical trial of MamaLift Plus, a digital therapeutic for women experiencing perinatal mood disturbances.
SuMMER is a national, randomized, placebo (sham)-controlled pivotal trial evaluating MamaLift Plus for eight weeks in 141 patients (ITT population) randomized in a 2:1 ratio to the MamaLift Plus arm (N = 95) and control (sham digital) arm (N = 46). Patients had baseline EPDS scores ≥ 13 but not exceeding 19, and a confirmed diagnosis of postpartum depression prior to enrollment.
The SuMMER trial met its primary endpoint, a ≥4-point improvement in Edinburgh Postnatal Depression Scale (EPDS) score. The EPDS is the most commonly used depression screening tool for the perinatal population, and an improvement of four or more points is clinically meaningful. Preliminary results indicate that approximately 83% of participants in the intervention arm achieved a ≥ 4-point improvement in EPDS score, compared to only 22% in the control arm (p-value < 0.001). Approximately 82% of patients in the intervention arm achieved an EPDS reduction to <13, compared to only 30% in the control arm (p-value < 0.001). Patients with EPDS scores ≥ 13 are candidates for interventional therapy.
“We are excited to see the data on this critical research endeavor. The positive results from the SuMMER trial underscore the efficacy of MamaLift Plus to address postpartum depression and improve the lives of women experiencing perinatal mood disturbances,” said Professor Stan Kachnowski, PhD, Principal Investigator and HITLAB Chair. “Our collaboration exemplifies HITLAB’s commitment to advancing women’s healthcare innovations, and we look forward to continuing to drive positive change in the field of digital therapeutics and mental health through rapid evidence generation.”
“We are delighted and encouraged by the strong findings from the SuMMER study,” said Shailja Dixit, Chief Executive Officer of Curio. “Digital therapeutics continue to be an important option for women suffering from depressive symptoms. We are profoundly grateful to the study participants and the research team for their contributions to this research. We look forward to continued guidance from the FDA to bring this important intervention to market.”
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