About 300 million people worldwide experience depression. Many symptoms underline their experience, with disturbed sleep being a common pattern. However, not enough research goes into unearthing if people with sleep disorders are suffering from more than just that. That’s where mental health tech company Medibio Limited (ASX: MEB) comes in.

The Company has achieved a milestone in its pursuit of advancing mental health diagnostics. It has completed the first phase of the Sleep Signal Analysis for Current Major Depressive Episode study (SAMDE) with promising initial results. The findings highlight the substantial potential of its algorithm to aid in the diagnosis of a current Major Depressive Episode (cMDE).

The clinical trial, focusing on detecting the likelihood of a current major depressive episode in individuals referred to sleep clinics for polysomnography (PSG) assessment (a test to measure bodily functions during sleep), marks a pivotal step in revolutionising depression screening procedures.

Preliminary results from the phase 1 trial surpassed the current international pooled average standard of care used for cMDE screening in individuals undergoing PSG assessments at sleep clinics. The trial enrolled 313 subjects across 12 sleep centers in five states in the U.S., demonstrating clinical and geographical diversity—an essential criterion according to the U.S. Food and Drug Administration (FDA) standards.

CEO Dr Tom Young said, “To have achieved these results based on preliminary testing, in the first phase of our SAMDE trial highlights the significant potential for the Company’s algorithmic offering when compared to the current standard of care. The preliminary results for the accuracy of our AI-based algorithm for the sensitivity component exceeded our expectations, and the initial indications now provide the Company with a strong framework for ongoing analysis of the phase 1 results through to the commencement of the phase 2 trial.” 

In phase 1, data was collected from 313 subjects, out of which 293 participants delivered usable data for algorithm development, involving 274 full-night studies and 19 split-night studies. Upon completion of approximately two-thirds of all trial participants, Medibio developed a cMDE detection algorithm using a selection of predictors that demonstrated the individual association with the self-administrated MINI cMDE test result. 

As the second phase of the SAMDE trial looms on the horizon, Medibio’s team remains eager to progress further in its mission. The second phase, with a target enrollment of 400 subjects, will involve clinicians administering the MINI test for each subject. This crucial step will pave the way for the upcoming clinical validation study, an imperative part of the Company’s FDA submission and clinical validation process. Phase 2 is expected to bolster the key measures of Medibio’s innovative algorithm.

Young added, “With enrolment for the second phase of the trial on schedule to start very soon, we look forward to providing more updates in the second half of 2023 on our comprehensive clinical trial strategy and regulatory roadmap, which will form the basis of a De Novo submission and potential FDA approval.” 

The Company expects to commence its Phase 2 trial shortly. With the potential to transform depression diagnostics, Medibio’s efforts hold the promise of improving mental health outcomes for many individuals.

Medibio ended the March 2023 quarter with $566k cash on hand compared to $318k in December 2022, and it continues to pursue funding opportunities.