TrivarX Limited (ASX: TRI) has completed on-boarding with a total of 15 sleep centres across the US to accelerate its phase 2 Sleep Signal Analysis for Current Major Depressive Episode study (SAMDE).
The study aims to continue to validate its innovative algorithm (MEB-001) to assist in the screening and diagnosis of a current major depressive episode (cMDE) in test subjects.
Completion of on-boarding follows considerable in-bound interest from industry participants since the launch of phase 2 in September 2023.
This included enquiries from Texas-based Comprehensive Sleep Medicine Associates (CSMA) which added three additional sites and took the total number of centres being utilised in the trial to 15, exceeding TrivarX’s initial target of 14. The company is confident that it will complete phase 2 testing during H1 CY2024.
Trivarx is seeking to test 400 patients during phase 2, which will see clinicians administer a Mini International Neuropsychiatric Interview (MINI) for each trial subject and provide an independent assessment of the underlying status of each subject to establish ground truth regarding cMDE status. To date, the company has successfully enrolled 132 of the 400 target patients.
Non-executive Chairman, David Trimboli, said commencement of Phase 2 follows promising initial results from the first phase trial, generated from 313 participants, tested through 12 sleep centres across five states in the US.
The preliminary results from sleep data collected during phase 1 indicated algorithm sensitivity of 71.65%, specificity of 71.43%, Positive Predictive Value of 35.38%, and Negative Predictive Value of 92.11% when tested within the development sample with a cross-validation protocol.
Preliminary Sensitivity results are promising with reference to current US industry standards, where data compiled by Kaiser Permanente for the US Department of Health & Human Services for clinician recognition of depression ranges from 21% to 76% of cases. Around 50% of these estimates fall above and the remainder fall below the international pooled average of 47.3%. Other studies have also reported a sensitivity of 49.3% and specificity of 81.1% for US primary care providers in accurately identifying cMDE.
TrivarX has made very pleasing progress in a short period in relation to phase 2 of its SAMDE trial and the on-boarding of an additional three sites with CSMA is expected to considerably fast track the initiative,” Mr Trimboli said.
“Phase 2 will provide the company with exceptional insight into how potentially valuable its innovative algorithm can be as a diagnostic screening tool. Results will also form the basis on Trivarx’s engagement with the FDA to unlock a regulatory pathway for our product, ahead of commercial roll out.
“The company’s focus remains on increasing patient enrolment over the coming weeks to achieve our target quota of 400 participants. We look forward to continuing our work with CSMA and the 12 other centres that have been on-boarded for the trial to achieve this.”
