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

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By Imelda Cotton - 
TriVarX ASX TRI Phase 2 SAMDE study
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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.

The 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.

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.

Regulatory validation

The 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.

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 (FDA).

“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.

Share placement

TrivarX conducted a $2.5 million share placement in May to fund the completion of the Phase 2 MEB-001 SAMDE study.

The company agreed to issue 100 million new shares in two tranches to professional, institutional and sophisticated investors from Australia and overseas.

“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.

“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.”