TrivarX completes Phase 2 MEB-001 algorithm sleep study for depressive episodes

Small Caps07-10

Medical health technology company TrivarX (ASX: TRI) has completed a Phase 2 sleep signal analysis for current major depressive episode (SAMDE) study utilising its proprietary artificial intelligence-...

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class=\"title\">\nTrivarX completes Phase 2 MEB-001 algorithm sleep study for depressive episodes\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-07-10 11:28 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://smallcaps.com.au/trivarx-phase-2-meb-001-algorithm-sleep-study-depressive-episodes/><strong>Small Caps</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Medical health technology company TrivarX (ASX: TRI) has completed a Phase 2 sleep signal analysis for current major depressive episode (SAMDE) study utilising its proprietary artificial intelligence-...</p>\n\n<a href=\"https://smallcaps.com.au/trivarx-phase-2-meb-001-algorithm-sleep-study-depressive-episodes/\">Source 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depressive episodes in 400 participants enrolled at 15 sleep centres across the US.It was based on clinicians administering a mini international neuropsychiatric interview and providing an independent assessment of the underlying status of each subject to establish ground truths regarding current major depressive episode status.TrivarX’s non-executive chair David Trimboli said the Phase 2 study results would provide regulatory validation for MEB-001 to assist the company’s engagement with the US Food and Drug Administration .“We are now rapidly undertaking data analysis on patient reports, which will be used to provide updated information on the performance of MEB-001,” he said.TrivarX conducted a $","collect":0,"end_time":0,"defaultTopTitle":"smallcaps.com.au","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK7094":"医疗保健技术","TRI.AU":"TRIVARX FPO"},"translate_title":"TrivarX完成针对抑郁发作的2期MEB-001算法睡眠研究","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"TRI.AU":1},"content_text":"Medical health technology company TrivarX (ASX: TRI) has completed a Phase 2 sleep signal analysis for current major depressive episode (SAMDE) study utilising its proprietary artificial intelligence-backed algorithm MEB-001.\nThe study aimed to validate MEB-001 in the screening and diagnosis of current major depressive episodes in 400 participants enrolled at 15 sleep centres across the US.\nIt was based on clinicians administering a mini international neuropsychiatric interview and providing an independent assessment of the underlying status of each subject to establish ground truths regarding current major depressive episode status.\nRegulatory validation\nThe study followed positive Phase 1 results last July indicating an algorithm sensitivity of 71.65%, a specificity of 71.43%, a positive predictive value of 35.38% and a negative predictive value of 92.11% when tested within the development sample using a cross-validation protocol.\nTrivarX’s non-executive chair David Trimboli said the Phase 2 study results would provide regulatory validation for MEB-001 to assist the company’s engagement with the US Food and Drug Administration (FDA).\n“We are now rapidly undertaking data analysis on patient reports, which will be used to provide updated information on the performance of MEB-001,” he said.\nShare placement\nTrivarX conducted a $2.5 million share placement in May to fund the completion of the Phase 2 MEB-001 SAMDE study.\nThe company agreed to issue 100 million new shares in two tranches to professional, institutional and sophisticated investors from Australia and overseas.\n“We expect this placement will provide the required balance sheet strength to capitalise on the recent momentum of our comprehensive clinical trial program for MEB-001,” Mr Trimboli said at the time.\n“The proceeds will support our ongoing engagement with US regulators following a positive meeting with the FDA in February where we established a clear pathway to regulatory approval.”","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; 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