The trial is designed to meet the Therapeutic Goods Administration's requirements for expedited drug approval.
() has commenced a recruitment campaign for participants in a clinical trial of a medicine for the treatment of depression.
The trial is being led by Queensland University of Technology (QUT) in Brisbane which is running the recruitment campaign.
Notably, two phase I trials have already shown significant patient improvement on the combination of Medlab’s NRGBiotic™ product with a standard anti-depressant medicine.
READ: Medlab Clinical Ltd initiates phase IIa after positive anti-depression results
The phase IIa study is designed to strengthen those initial findings in a wider group of patients, with the recruitment campaign intended to enrol 150 people diagnosed with depression.
Medlab’s trial design is intended to meet the requirements of a new expedited drug approval mechanism being developed by the Department of Health’s Therapeutic Goods Administration (TGA) to provide faster access to new medicines which have a community benefit.
The company has already received approval of a grant from the Federal government towards the cost of this trial.
The research underlying the trial is based on a connection between gut health and inflammation and its subsequent effect on mental health.
Globally, more than 300 million people suffer from depression.
In Australia, 45% of people aged 16-85 years have met the criteria for a diagnosis of a mental disorder at some point in their lives and the annual cost of mental illness is $20 billion.
Medlab managing director Dr Sean Hall said there was a clear community need to develop more effective medicines for the treatment of depression.
Hall added “Recruitment for our trial is underway and we hope that in reaching out to those with treatment-resistant depression we can make a difference to their lives as well as developing a medicine for the wider community.”
READ: Medlab Clinical on schedule with medicinal cannabis cancer trial
As well as developing bacteria-based medicines for treating depression, diabetes and chronic kidney disease, Medlab has developed two cannabis-based medicines for oncology patients.
One medicine is used for pain management and the other for seizures, nausea and vomiting, with the first undergoing a clinical trial with seriously ill cancer patients at Royal North Shore Hospital in Sydney.
In the cannabis clinical trial, Medlab’s NanaBis™ will be administered by Medlab’s small particle medicine delivery platform, NanoCelle™.
Medlab also sells Testo Restore, an evidence-based formulation designed to increase free testosterone levels and support muscle strength and recovery.