DIR 221 - Clinical trial of a genetically modified Escherichia coli for the treatment of ulcerative colitis

Between 27 November 2025 and 14 January 2026, we sought your feedback on the consultation version of the Risk Assessment and Risk Management Plan (RARMP) prepared for the DIR 221 licence application (Clinical trial of a genetically modified (GM) Escherichia coli for the treatment of ulcerative colitis from Melius MicroBiomics Pty Ltd).

During the 7-week consultation period, we received advice from prescribed Government agencies, and the Gene Technology Technical Advisory Committee.

We heard support for:

• the overall conclusions of the RARMP
• the licence conditions for DIR 221.

We heard concerns for:

• potential negative impacts on people and the environment
• the limits and controls proposed in the draft licence.

We analysed the feedback provided during the public consultation process in finalising the RARMP. The issues raised and how they were addressed can be found in Appendix A of the final RARMP.

The Gene Technology Regulator issued a licence to Melius MicroBiomics Pty Ltd for the clinical trial with the GM E. coli on 4 February 2026. More details, including the final version of the RARMP and the licence, are available at DIR 221 | Office of the Gene Technology Regulator.

We appreciate all those who provided input to the consultation – your feedback will help to ensure that any risks posed by gene technology to people and the environment continue to be managed