TrivarX (ASX: TRI) has submitted a formal request to the US Food & Drug Administration (FDA) for a pre- submission meeting to approve the design for a proposed pivotal trial which will test its proprietary AI- driven algorithm MEB-001.
MEB-001 can greatly assist with the effective screening of current Major Depressive Episode (cMDE). There is currently no clinically-backed screening solution for cMDE utilised by sleep centres in the US or globally.
The request follows from the company’s successful Phase 2 SAMDE study, which demonstrated the effectiveness of MEB-001 in screening for cMDE – a condition which is commonly under or misdiagnosed.
Following the successful results of the Phase 2 SAMDE Study, TrivarX is proceeding to a pivotal trial to confirm the effectiveness of the MEB-001 algorithm in screening for a cMDE.
After multiple productive pre-submission meetings with the FDA, this next FDA meeting is expected to finalise the clinical trial protocol for the pivotal trial. This trial is the final requirement before TrivarX can submit MEB-001 for FDA approval via the De Novo pathway.
The company expects to undertake the meeting with the FDA next quarter. Upon completion of the pre- submission meeting, TrivarX plans to commence the pivotal trial, aiming for an FDA submission in H1 CY2025.
Following the Phase 2 results, several prominent US sleep centres and research organisations have expressed interest in collaborating on the pivotal trial. These partnerships will help fast-track the trial’s completion at high-volume sites.
“Today’s announcement marks the next step forward in our clinical development pathway, which is advancing well in close consultation with the FDA and our research partners,” Non-Executive Chairman, David Trimboli, said.
“We are working closely with the FDA to finalise the pivotal trial protocol, which will be very similar to the Company’s Phase 2 SAMDE trial, to test the effectiveness of MEB-001 in improved screening for a current Major Depressive Episode (cMDE).
“This pivotal trial will be our final clinical step before FDA submission, bringing us closer to commercialising MEB-001.
“We are excited about the potential of MEB-001 to drive significant positive health outcomes. We look forward to providing more updates heading into the coming months as TrivarX continues to execute on our clinical development strategy.”
