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..

普林斯頓，新澤西州-（商業(yè)線(xiàn)）-Curio Digital Therapeutics，Inc.（“Curio”）今天宣布了支持孕產(chǎn)婦心理健康和情緒調(diào)節(jié)（SuMMER）試驗(yàn)的積極數(shù)據(jù)。夏季（NCT05958095）是由著名的醫(yī)療保健創(chuàng)新和研究組織HITLAB執(zhí)行的一項(xiàng)研究，是MamaLift Plus的隨機(jī)臨床試驗(yàn)，MamaLift Plus是一種針對(duì)圍產(chǎn)期情緒障礙女性的數(shù)字治療藥物。。

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是一項(xiàng)全國(guó)性，隨機(jī)，安慰劑（假）對(duì)照的關(guān)鍵性試驗(yàn)，評(píng)估了141名患者（ITT人群）的MamaLift Plus 8周，該患者以2:1的比例隨機(jī)分配到MamaLift Plus組（N=95）和對(duì)照組（sham digital）手臂（N=46）?；颊叩幕€(xiàn)EPDS評(píng)分≥13但不超過(guò)19，并且在入組前確診為產(chǎn)后抑郁癥。。

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).

夏季試驗(yàn)符合其主要終點(diǎn)，愛(ài)丁堡產(chǎn)后抑郁量表（EPDS）評(píng)分改善≥4分。EPDS是圍產(chǎn)期人群最常用的抑郁癥篩查工具，改善四分或更多分具有臨床意義。初步結(jié)果顯示，干預(yù)組約83%的參與者EPDS評(píng)分改善≥4分，而對(duì)照組僅為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..

干預(yù)組約82%的患者EPDS降至<13，而對(duì)照組僅為30%（p值<0.001）.EPDS評(píng)分≥13的患者為介入治療的候選人。。

'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.

“我們很高興看到這項(xiàng)重要研究工作的數(shù)據(jù)。夏季試驗(yàn)的積極結(jié)果強(qiáng)調(diào)了MamaLift Plus在解決產(chǎn)后抑郁癥和改善圍產(chǎn)期情緒障礙婦女生活方面的功效，“首席研究員兼HITLAB主席Stan Kachnowski教授博士說(shuō)。

“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.”.

“我們的合作體現(xiàn)了HITLAB致力于推進(jìn)女性醫(yī)療保健創(chuàng)新的承諾，我們期待通過(guò)快速的證據(jù)生成繼續(xù)推動(dòng)數(shù)字治療和心理健康領(lǐng)域的積極變革?！?。

“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首席執(zhí)行官Shailja Dixit說(shuō)：“我們對(duì)夏季研究的有力發(fā)現(xiàn)感到高興和鼓舞。“數(shù)字療法仍然是患有抑郁癥狀的女性的重要選擇。我們非常感謝研究參與者和研究團(tuán)隊(duì)對(duì)這項(xiàng)研究的貢獻(xiàn)。

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

我們期待FDA繼續(xù)指導(dǎo)將這一重要干預(yù)措施推向市場(chǎng)?！薄?/p>

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.

居里奧感謝夏季調(diào)查人員及其研究團(tuán)隊(duì)在進(jìn)行成功試驗(yàn)方面的合作。Curio要感謝其臨床工作人員，包括醫(yī)療監(jiān)督員和持牌心理健康提供者，感謝他們對(duì)患者安全的承諾。Curio還要感謝夏季研究的參與者，沒(méi)有他們，這項(xiàng)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..

感謝與會(huì)者與我們分享您的經(jīng)驗(yàn)，并為此為所有女性都能獲得循證行為醫(yī)療保健的愿景做出貢獻(xiàn)。。

About Curio Digital Therapeutics, Inc.

關(guān)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。是為女性開(kāi)發(fā)整個(gè)生命周期數(shù)字治療解決方案和新型神經(jīng)行為干預(yù)的先驅(qū)。居里奧的目標(biāo)是創(chuàng)造一個(gè)世界，讓每個(gè)女性都可以通過(guò)指尖獲得行為健康解決方案。Curio平臺(tái)正在利用專(zhuān)有算法，臨床驗(yàn)證的篩查工具和個(gè)性化的數(shù)字神經(jīng)行為干預(yù)措施，重塑孕產(chǎn)婦心理健康護(hù)理，以促進(jìn)及時(shí)識(shí)別和護(hù)理。

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

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，是一家領(lǐng)先的循證醫(yī)療保健創(chuàng)新實(shí)驗(yàn)室，專(zhuān)門(mén)從事世界級(jí)數(shù)字健康研究和教育。我們幫助領(lǐng)先的組織構(gòu)思，創(chuàng)建和評(píng)估基于技術(shù)的解決方案，以應(yīng)對(duì)全球緊迫的醫(yī)療保健挑戰(zhàn)。

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與公共和私營(yíng)部門(mén)的各種利益相關(guān)者合作，設(shè)計(jì)和傳播改善醫(yī)療保健服務(wù)和交付的研究，計(jì)劃和產(chǎn)品。www.hitlab.org。

Forward-Looking Statements

前瞻性聲明

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..

本新聞稿包含1995年“私人證券訴訟改革法”含義內(nèi)的前瞻性聲明。這些前瞻性陳述通常由“相信”，“項(xiàng)目”，“期望”，“預(yù)期”，“估計(jì)”，“意圖”，“策略”，“未來(lái)”，“機(jī)會(huì)”，“計(jì)劃”，“可能”，“應(yīng)該”，“將會(huì)”，“將會(huì)”，“將繼續(xù)”，“可能會(huì)結(jié)果”，包括但不限于，關(guān)于MamaLift和MamaLift Plus的聲明。。

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..

這些前瞻性陳述基于庫(kù)里奧及其管理層認(rèn)為合理的預(yù)測(cè)，估計(jì)和假設(shè)。但是，它們固有地受到風(fēng)險(xiǎn)和不確定性的影響?？赡軐?dǎo)致實(shí)際結(jié)果與本新聞稿所載任何前瞻性陳述所表達(dá)或暗示的結(jié)果有重大差異的因素包括但不限于：（i）供應(yīng)商長(zhǎng)期或延遲采用居里產(chǎn)品，（ii）患者不愿使用居里產(chǎn)品，（iii）居里產(chǎn)品可能受到經(jīng)濟(jì)不利影響的可能性，商業(yè)，監(jiān)管和/或競(jìng)爭(zhēng)因素，（iv）居里奧經(jīng)營(yíng)市場(chǎng)的演變或政策變化，（v）以及新型冠狀病毒肺炎的影響，包括新的公共衛(wèi)生封鎖措施或新病毒株的出現(xiàn)病毒，對(duì)居里奧的業(yè)務(wù)。。

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.

居里奧警告讀者不要過(guò)分依賴(lài)前瞻性陳述，這些陳述只有在他們作出之日才是最新的。Curio不承擔(dān)根據(jù)未來(lái)或其他方面的新期望或事件更新，重申或修改任何此類(lèi)前瞻性陳述的義務(wù)。

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網(wǎng)址: Curio Digital Therapeutics宣布產(chǎn)后抑郁癥的關(guān)鍵試驗(yàn)數(shù)字治療達(dá)到療效終點(diǎn) http://www.u1s5d6.cn/newsview1552761.html