PRINCETON, N.J.--(BUSINESS WIRE)--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.”
Acknowledgments
Curio extends its appreciation to the SuMMER investigators and their research teams for their collaboration in conducting a successful trial. Curio would like to thank its clinical staff, including medical monitors and licensed mental health providers, for their commitment to patient safety. Curio would also like to thank the SuMMER study participants, without whom this important research would not have been possible. Thank you to the participants for sharing your experiences with us and, in so doing, contributing to a vision where all women have access to evidence-based behavioral health care.
About Curio Digital Therapeutics, Inc.
Curio Digital Therapeutics, Inc. is a pioneer in developing digital therapeutics solutions and novel neurobehavioral interventions across the lifecycle for women. Curio aims to create a world where every woman can access a behavioral health solution at her fingertips. The Curio Platform is reshaping maternal mental health care by leveraging proprietary algorithms, clinically validated screening tools, and personalized digital, neurobehavioral interventions to facilitate timely identification and care. For more information, visit Curio at https://www.curiodigitaltx.com/.
ABOUT HITLAB
Established in 1998, HITLAB is a leading evidence-based, healthcare innovation lab specializing in the delivery of world-class digital health research and education. We help leading organizations ideate, create, and evaluate technology-based solutions to pressing healthcare challenges across the globe. HITLAB works with a wide variety of stakeholders in both the public and private sectors to design and disseminate studies, programs, and products that improve healthcare access and delivery. www.hitlab.org
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions and include, but are not limited to, statements regarding MamaLift and MamaLift Plus.
These forward-looking statements are based upon projections, estimates, and assumptions that are considered reasonable by Curio and its management. However, they are inherently subject to risks and uncertainties. Factors that may cause actual results to differ materially from those expressed or implied by any forward-looking statements contained in this press release include, but are not limited to, (i) Protracted or delayed adoption of Curio products by providers, (ii) Reluctance on the part of patients to use Curio products, (iii) The possibility that Curio may be adversely affected by economic, business, regulatory, and/or competitive factors, (iv) Evolution or policy changes in the markets in which Curio operates, (v) and the impact of COVID-19, including new public health lockdown measures or the emergence of new strains of the virus, on Curio’s business.
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