Ann: Positive Results from Phase 2 SAMDE Study, page-16

Non-executive chairman David Trimboli said the Phase 2 results highlight the effectiveness of MEB-001 in screening for cMDE, particularly given improvements to the underlying algorithm.

“This is underscored by the significant increase in sensitivity coming from recent improvements to the underlying algorithm, which increased from 71% in Phase 1 to 87% in Phase 2 – demonstrating that the algorithm can successfully identify more people with cMDE,” he said.

The Negative Predictive Value (NPV) of 97% is another important indicator of the quality of the results, highlighting that where MEB-001 assessed that a patient didn’t have depression it was accurate 97% of the time.

Just as importantly, the Positive Predictive Value (PPV) of 35% is a strong result, and places MEB-001 at the upper end of the industry standard for effective depression screening.

In aggregate, the results equate to a significant derisking event for TrivarX, highlighting the technology’s potential use-case in a market where there is no established competitor or incumbent technology for improved depression screening and diagnostics.

“There is currently no screening undertaken for cMDE in sleep centres in the US or globally and our most recent results reaffirm the potential of MEB-001 to become the first depression screening tool used in clinical practice in sleep centres – thus marking a significant achievement in the company’s history.” Trimboli added.