Licence details
Melius MicroBiomics Pty Ltd
Escherichia Coli
Human therapeutic
This licence allows Melius MicroBiomics Pty Ltd to conduct a clinical trial of a genetically modified (GM) Escherichia coli for the treatment of ulcerative colitis.
The GMO is based on the E. coli Nissle probiotic strain, which has been used for over 100 years. The GM E. coli has been modified by the insertion of a gene that allows it to persist longer in inflammatory conditions, common in the gut of people with ulcerative colitis. The GM E. coli has also been modified to reduce its ability to persist outside the body in the broader environment.
The GMO will be manufactured overseas and imported into Australia. Up to 36 participants will receive the GMO at hospital and clinical trial sites in Brisbane, over a period of 5 years.
The RARMP concluded that the clinical trial poses negligible to low risks to people and negligible risks to the environment. Licence conditions have been imposed to manage these risks.
The risk analysis for this application was carried out in accordance with the Regulator’s Risk Analysis Framework.
Documents
Outlines the Regulator’s decision to issue a licence following the assessment of this application.
FAQs on the licence application and the Regulator’s decision to issue a licence for this application.
A summary of the Risk Assessment and Risk Management Plan prepared as part of the assessment of this application. It provides a brief description of the licence application, the risk assessment and risk management plan.
The final risk assessment and management plan prepared to support the Regulator's decision. It describes the GMO(s) and proposed work with the GMO(s) and provides an assessment of potential risks posed by the GMO(s). It also includes a summary of submissions received during the public consultation process.
Sets out the licence conditions imposed by the Regulator, including the licence holder’s general and specific obligations and reporting requirements.