Participants in the Phase 1 human trials were administered a Medlab formulation named NRGBiotic to assess whether it could improve depression symptoms and clinical outcomes.
The first trial of eight weeks showed significant improvement in 80% of the trial cohort, with the second trial of the same period showing further improvement in +90% of the trial cohort.
Medlab is proceeding immediately to Phase 2a human clinical studies on the basis of these significant results.
In initiating the Phase I trial, Medlab hypothesised that treatment-resistant depression may be due to a combination of altered neurophysiological and poor gut health issues.
The hypothesis has been influenced by the Human Microbiome Project, a five year project by the U.S. National Institute of Health aimed at understanding the role of bacteria living in and on humans.
Medlab has formulated NRGBiotic as a bacteria-based medicine that targets the gut–brain axis to treat patients diagnosed with treatment-resistant depression.
Importantly, the outcomes from the Phase I trial were positive for the underlying hypothesis and the application of NRGBiotic.
The Australian Bureau of Statistics has estimated 45% of Australians aged 16-85 years have met the criteria for a diagnosis of a mental disorder at some point in their lives.
Medlab is looking to participate in Australia’s mental illness market which costs the country in the order of $20 billion annually.
The company’s share price has increased by 80% during the past 6 months, trading at $0.375.
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