Curio Digital Therapeutics has unveiled promising data from the Supporting Maternal Mental Health and Emotional Regulation (SuMMER) trial, a study carried out in collaboration with HITLAB. The trial focuses on evaluating the effectiveness of MamaLift Plus, a digital therapeutic designed to support women dealing with perinatal mood disturbances.
SuMMER, a nationwide, randomized, placebo-controlled trial, spanned eight weeks and involved 141 participants. These participants were divided into the MamaLift Plus arm (N = 95) and the control (sham digital) arm (N = 46), all of whom had baseline Edinburgh Postnatal Depression Scale (EPDS) scores between ≥ 13 and 19 and were previously diagnosed with postpartum depression.
The SuMMER trial met its primary endpoint, which required a ≥4-point improvement in the EPDS score. Preliminary findings indicate that approximately 83% of participants in the MamaLift Plus arm achieved this improvement, compared to only 22% in the control arm (p-value < 0.001). Additionally, around 82% of MamaLift Plus arm participants saw their EPDS score drop below 13, compared to 30% in the control arm (p-value < 0.001). This improvement is clinically meaningful, as patients with EPDS scores ≥ 13 are suitable 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.”
