TrivarX (ASX: TRI) has recruited with 362 of 400 patients for its phase 2 Sleep Signal Analysis for Current Major Depressive Episode (SAMDE) study.
The study is using the company’s u proprietary AI-backed algorithm, MEB-001.
The company expects to complete the trial in the coming weeks and report results shortly thereafter. TrivarX is confident that any positive data from the study will provide further regulatory validation for its proprietary algorithm prior to further engagement with the US Food and Drug Administration (FDA).
The company has also appointed a US-based strategic advisor to assist with advancing commercial opportunities associated with TrivarX’s innovative product suite.
Drew Palin M.D. is has been named as a strategic advisor to advance a number of corporate opportunities. He is a seasoned healthcare executive and an innovative entrepreneur with over 30 years of experience in the medical technology sector.
As part of his role, Mr Palin will assist the company in advancing a number of commercial opportunities including additional partnership agreements, licencing opportunities and commercialisation initiatives.
“The successful patient enrolment to date for TrivarX’s comprehensive Phase 2 SAMDE study is a testament to the hard work of our clinical field team and research partners – all of whom have consistently operated at a high level to bring a trial of this scale towards completion,” Non-Executive Chairman, David Trimboli, said.
“We remain fully committed to our development pathway for the MEB- 001 algorithm – a clinically-backed AI solution that aims to provide more effective screening of a current Major Depressive Episode (cMDE) and achieve improved patient health outcomes.
“Heading into the second half of the 2024 calendar year, the company looks forward to providing key updates as the results of the Phase 2 study are received, which will in turn support ongoing dialogue with the US FDA where the company has already established a clear route to regulatory approval for MEB-001 through the De Novo pathway.”