November 2025

Invitation to comment on a clinical trial of a genetically modified Escherichia coli for the treatment of ulcerative colitis (DIR 221)

The Gene Technology Regulator is assessing an application from Melius MicroBiomics Pty Ltd to conduct a clinical trial, under limited and controlled conditions, of a genetically modified Escherichia coli for the treatment of ulcerative colitis. The trial is proposed to take place at a hospital or clinical trial sites in Brisbane. Up to 36 trial participants would be treated over a 5-year period.

The Regulator has prepared a Risk Assessment and Risk Management Plan (RARMP) for this application and welcomes written submissions relating to the protection of human health and safety and the environment prior to making a decision on whether to issue the licence. The consultation RARMP and related information can be obtained via the consultation hub at https://consultations.health.gov.au/ogtr/dir-221-consultation, or from the contacts below. Submissions should reference DIR 221 and be received by 14 January 2026.

Office of the Gene Technology Regulator
MDP 54 GPO Box 9848 CANBERRA ACT 2601

Telephone: 1800 181 030   Website: www.ogtr.gov.au

E-mail: ogtr@health.gov.au