TrivarX seeks FDA meeting to advance trial of AI-based depression-screening tech

TrivarX files requests for US FDA pre-submission meeting to approve design of upcoming pivotal trial
Trial to test AI-driven algorithm MEB-001 to assist with screening of current Major Depressive Episode (cMDE) via sleep monitoring
Chief Development Officer of one of the US’s largest sleep disorder diagnostic outsourced service providers and industry veteran appointed to board

Special Report: TrivarX has made a major move to advance a proposed pivotal trial of its AI-driven algorithm MEB-001 to assist with screening of current Major Depressive Episode (cMDE) via sleep monitoring, while also strengthening its board through a key appointment.

TrivarX (ASX:TRI) has filed 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.

The request follows TRI’s successful Phase 2 SAMDE study, which demonstrated the effectiveness of MEB-001 in screening for cMDE – a condition commonly under or misdiagnosed.

Following the successful results of the Phase 2 SAMDE study, TRI is proceeding to a pivotal trial to confirm the effectiveness of the MEB-001 algorithm in screening for cMDE.

TRI has had multiple productive pre-submission meetings with the FDA previously and with its next meeting, the regulator is expected to approve the clinical trial protocol for the company’s upcoming pivotal trial. The 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 pre-submission meeting with the FDA next quarter before it kicks off the pivotal trial, aiming for an FDA submission in H1 CY2025.

Following the Phase 2 results, TRI said several prominent US sleep centres and research organisations have expressed interest in collaborating on the pivotal trial, which would fast-track the trial’s completion at high-volume sites.

‘Excited about the potential of MEB-001’

TRI said the AI-driven screening and diagnostic tool can greatly assist in the screening and long-term monitoring of mental illness and mood disorders, which are still an overlooked area of sleep studies.

TRI said a connection between sleep disturbances and mental health is well known. However, there was no screening for mental health disorders in sleep clinics in the US or globally.

Non-executive chairman David Trimboli said the company was working closely with the FDA to finalise the pivotal trial protocol, which will be very similar to its Phase 2 SAMDE trial, to test the effectiveness of MEB-001 in improving the screening for cMDE.

“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,” he said.

“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.

Key board appointment

TRI said it had also “strengthened the composition” of its board with the appointment of experienced healthcare-focused operations and business development executive John H. Mathias II as a non-executive director.

TRI said Mathias, who has a clinical background in respiratory care and track record of success over a 30-year career in the US healthcare industry, would take up his board position on October 1.

He currently holds the role of chief development officer at Medbridge Healthcare, which is one of the largest sleep disorder diagnostic outsourced service providers in the US and performs more than 80,000 sleep diagnostic procedures annually.

Medbridge also has several professional partnerships that support adjacent services, including hospital readmission reduction programs (HRRP), product and drug research, occupational health, professional services, and therapeutic sleep offerings.

As chief development officer, TRI said Mathias plays a central role in building partnerships with stakeholders across the US healthcare system in the field of sleep medicine, including hospitals, medical research institutions, clinical partnerships, and insurance companies.

Mathias also served as chief operating officer and president of Sleep Services of America Inc.

TRI said throughout his career he has been recognised for building and leading high-performing healthcare managers and sales teams and implementing strategic business plans to drive consistent growth in revenue and margins.

TRI said Mathias’s core areas of expertise include contract management services for sleep and respiratory services, acute care hospital operations, and developing improved patient solutions in the aged-care industry.

Trimboli said his appointment provides the board with additional depth and expertise as it moves from clinical development towards regulatory approval and commercialisation of its proprietary MEB-001 algorithm for the effective screening of cMDE in the US market.

“It’s my pleasure to welcome John to the board at this important juncture in the Company’s development and commercialisation pathway,” he said.

“As we advance our strategy for regulatory approval and commercialisation for MEB-001, we continue to maintain dialogue with regulators, research partners, and healthcare providers.

“In that context, John’s extensive experience across the US health system, with specific expertise in the operation of sleep diagnostic centres, is ideally suited to assist with both business development as well as logistics and planning for the potential application of our technology.”

This article was developed in collaboration with TrivarX, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.