首页 > 资讯 > Curio Digital Therapeutics宣布产后抑郁症的关键试验数字治疗达到疗效终点

Curio Digital Therapeutics宣布产后抑郁症的关键试验数字治疗达到疗效终点

泰然健康网
2025-07-14 15:04

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..

普林斯顿，新泽西州-（商业线）-Curio Digital Therapeutics，Inc.（“Curio”）今天宣布了支持孕产妇心理健康和情绪调节（SuMMER）试验的积极数据。夏季（NCT05958095）是由着名的医疗保健创新和研究组织HITLAB执行的一项研究，是MamaLift Plus的随机临床试验，MamaLift Plus是一种针对围产期情绪障碍女性的数字治疗药物。。

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..

SuMMER是一项全国性，随机，安慰剂（假）对照的关键性试验，评估了141名患者（ITT人群）的MamaLift Plus 8周，该患者以2:1的比例随机分配到MamaLift Plus组（N=95）和对照组（sham digital）手臂（N=46）。患者的基线EPDS评分≥13但不超过19，并且在入组前确诊为产后抑郁症。。

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).

夏季试验符合其主要终点，爱丁堡产后抑郁量表（EPDS）评分改善≥4分。EPDS是围产期人群最常用的抑郁症筛查工具，改善四分或更多分具有临床意义。初步结果显示，干预组约83%的参与者EPDS评分改善≥4分，而对照组仅为22%（p值<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..

干预组约82%的患者EPDS降至<13，而对照组仅为30%（p值<0.001）.EPDS评分≥13的患者为介入治疗的候选人。。

'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.

“我们很高兴看到这项重要研究工作的数据。夏季试验的积极结果强调了MamaLift Plus在解决产后抑郁症和改善围产期情绪障碍妇女生活方面的功效，“首席研究员兼HITLAB主席Stan Kachnowski教授博士说。

“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.”.

“我们的合作体现了HITLAB致力于推进女性医疗保健创新的承诺，我们期待通过快速的证据生成继续推动数字治疗和心理健康领域的积极变革。”。

“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.

Curio首席执行官Shailja Dixit说：“我们对夏季研究的有力发现感到高兴和鼓舞。“数字疗法仍然是患有抑郁症状的女性的重要选择。我们非常感谢研究参与者和研究团队对这项研究的贡献。

We look forward to continued guidance from the FDA to bring this important intervention to market.”.

我们期待FDA继续指导将这一重要干预措施推向市场。”。

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.

居里奥感谢夏季调查人员及其研究团队在进行成功试验方面的合作。Curio要感谢其临床工作人员，包括医疗监督员和持牌心理健康提供者，感谢他们对患者安全的承诺。Curio还要感谢夏季研究的参与者，没有他们，这项重要的研究是不可能的。

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..

感谢与会者与我们分享您的经验，并为此为所有女性都能获得循证行为医疗保健的愿景做出贡献。。

About Curio Digital Therapeutics, Inc.

关于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.

Curio Digital Therapeutics，Inc。是为女性开发整个生命周期数字治疗解决方案和新型神经行为干预的先驱。居里奥的目标是创造一个世界，让每个女性都可以通过指尖获得行为健康解决方案。Curio平台正在利用专有算法，临床验证的筛查工具和个性化的数字神经行为干预措施，重塑孕产妇心理健康护理，以促进及时识别和护理。

For more information, visit Curio at https://www.curiodigitaltx.com/..

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成立于1998年，是一家领先的循证医疗保健创新实验室，专门从事世界级数字健康研究和教育。我们帮助领先的组织构思，创建和评估基于技术的解决方案，以应对全球紧迫的医疗保健挑战。

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.

HITLAB与公共和私营部门的各种利益相关者合作，设计和传播改善医疗保健服务和交付的研究，计划和产品。www.hitlab.org。

Forward-Looking Statements

前瞻性声明

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..

本新闻稿包含1995年“私人证券诉讼改革法”含义内的前瞻性声明。这些前瞻性陈述通常由“相信”，“项目”，“期望”，“预期”，“估计”，“意图”，“策略”，“未来”，“机会”，“计划”，“可能”，“应该”，“将会”，“将会”，“将继续”，“可能会结果”，包括但不限于，关于MamaLift和MamaLift Plus的声明。。

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..

这些前瞻性陈述基于库里奥及其管理层认为合理的预测，估计和假设。但是，它们固有地受到风险和不确定性的影响。可能导致实际结果与本新闻稿所载任何前瞻性陈述所表达或暗示的结果有重大差异的因素包括但不限于：（i）供应商长期或延迟采用居里产品，（ii）患者不愿使用居里产品，（iii）居里产品可能受到经济不利影响的可能性，商业，监管和/或竞争因素，（iv）居里奥经营市场的演变或政策变化，（v）以及新型冠状病毒肺炎的影响，包括新的公共卫生封锁措施或新病毒株的出现病毒，对居里奥的业务。。

Curio cautions readers not to put undue reliance on forward-looking statements, which are current only as of the date they were made. Curio assumes no obligation to update, restate, or revise any such forward-looking statements in light of new expectations or events, future or otherwise.

居里奥警告读者不要过分依赖前瞻性陈述，这些陈述只有在他们作出之日才是最新的。Curio不承担根据未来或其他方面的新期望或事件更新，重申或修改任何此类前瞻性陈述的义务。