Medlab Clinical Limited (ASX: MDC) has been granted ethics approval for a Phase 2a human trial for its anti-depression program following positive outcomes from two Phase 1 clinical trials.
The phase 2a clinical trial is testing Medlab’s product NRGBiotic on patients diagnosed with depression. Previous trials demonstrated the formulation effectively improved symptoms and quality of life for patients with drug resistant depression.
NRGBiotic (patent pending) is a bacteria-based (probiotic) medicine that targets the gut–brain axis and improvement of gut health, with the goal of improving the body’s ability to absorb medicine. The product (NRGBiotic) is currently available in Australia and New Zealand as part of Medlab’s nutritional range.
According to Medlab CEO, Mr Sean Hall, it was encouraging to get such support from the ethics committee, representing an accelerated progression of the trial into Phase 2a.
“Potential outcomes from the Phase 2 trial could be significant given the size of the market and the number of people in our Australian and NZ communities with depression. Medlab strongly believes that our NRGBiotic product will have global demand,” said Mr Hall.
“We anticipate the clinical trial to involve the recruitment of 130 participants who fall into the particular category of depressed patients, following a similar design to the prior, successfully completed Phase 1 trials.”
Depression is the leading cause of disability worldwide. In Australia, it is estimated 45 per cent of people will experience a mental health condition in their lifetime and, in any one year, around 1 million Australian adults suffer from depression.
Dr Matthew Bambling will continue as the Principal Investigator, with the trial being conducted at the University of Queensland, Clinical Centre for Research.
Patients recruited for this trial could have been prescribed standard anti-depressant medication (SSRI), with no symptoms improvement and divided into either the control or experimental group.