TrivarX Faces Crucial Trial Phase After Positive FDA Meeting on MEB-001
TrivarX has secured positive feedback from the FDA on its pivotal trial design for MEB-001, an AI-driven algorithm targeting major depressive episode screening via sleep study data. The company is advancing site collaborations to launch a large-scale US trial.
- FDA endorses TrivarX's adaptive pivotal trial design for MEB-001
- Trial to recruit at least 563 patients across multiple US sleep clinics
- MEB-001 algorithm previously showed 87% sensitivity and 72% specificity
- Engagement with prominent hospitals progressing to secure high-volume sites
- Final trial before FDA De Novo submission for regulatory clearance
Regulatory Milestone for MEB-001
TrivarX Limited (ASX: TRI) has taken a significant step forward in the regulatory pathway for its AI-powered mental health screening tool, MEB-001. Following a pre-submission meeting with the US Food and Drug Administration (FDA), the company received clear validation of its proposed pivotal trial design. This endorsement provides TrivarX with renewed confidence as it prepares to initiate a large-scale clinical study aimed at securing FDA clearance via the De Novo pathway.
MEB-001 leverages artificial intelligence and machine learning to analyze biometric signals, such as EEG, ECG, and heart rate variability, collected during in-clinic sleep studies. Its goal is to assist clinicians in screening for current Major Depressive Episode (cMDE), a condition notoriously difficult to diagnose objectively. The algorithm’s promising Phase 2 trial results, with an 87% sensitivity and 72% specificity in a cohort of 400 patients, laid the groundwork for this pivotal study.
Adaptive Trial Design and Site Selection
The upcoming trial will adopt an adaptive design, enabling interim data analyses to potentially refine study parameters as it progresses. TrivarX plans to enroll a minimum of 563 patients aged 22 to 75 years who have been referred to sleep clinics for disturbances. The trial will be conducted across at least five US sites, with patient screening outcomes compared against the MINI Module A diagnostic standard, recognized by the FDA as a gold standard for cMDE diagnosis.
Crucially, TrivarX is actively engaging with prominent hospitals and sleep centers to secure high-volume clinical sites. These collaborations are expected to accelerate patient recruitment and enhance the trial’s robustness. The company’s management has expressed optimism about these partnerships, highlighting strong industry interest and the potential to unlock multiple key locations.
Strategic Implications and Market Positioning
For TrivarX, this FDA engagement marks a pivotal moment in its journey to commercialize MEB-001. Successful trial completion and subsequent regulatory approval would position the company at the forefront of mental health technology, offering an objective, data-driven tool to aid in depression screening. This could address a significant unmet need in clinical psychiatry, where subjective assessments currently dominate.
In addition, the company’s dual presence in Australia and the US underscores its ambition to capture international markets. The FDA’s positive feedback not only validates the scientific rigor behind MEB-001 but also signals potential investor confidence as TrivarX advances toward market entry.
While the pathway ahead still hinges on trial outcomes and regulatory review, the current momentum sets a promising tone for TrivarX’s growth trajectory in the burgeoning mental health technology sector.
Bottom Line?
TrivarX’s FDA-backed trial design sets the stage for a critical test of MEB-001’s potential to transform depression screening.
Questions in the middle?
- Will the pivotal trial replicate or improve upon the Phase 2 sensitivity and specificity metrics?
- Which US sleep centers will partner with TrivarX, and how quickly can patient recruitment scale?
- How might FDA feedback evolve following interim analyses in the adaptive trial?
