Perth biotech clears crucial manufacturing test for Crohn's disease therapy
Miro Sciences passed a TGA manufacturing audit, clearing the path for human trials of its stem-cell Crohn's therapy.
Perth-based biotech Miro Sciences has cleared a major manufacturing hurdle. Australia's Therapeutic Goods Administration completed an inspection of Q-Gen Cell Therapeutics' Brisbane facility.
The audit checked production of StemSmart, Miro's patented stem cell technology. The technology was developed at Royal Perth Hospital using stem cells from human bone marrow.
Miro plans to start a phase-two human trial before the end of 2026. The trial will target refractory Crohn's disease, a severe form that no longer responds to standard treatments.
Earlier trials showed 78 per cent of patients had a response. A further 44 per cent reached remission.
The TGA inspection removes a major regulatory barrier to starting the trial.
- 78% response rate, 44% remission
- Cost savings in trials
- Q-Gen Cell Therapeutics, Brisbane
- Manufacturing partner
- Before end of 2026
- Trial start window
- 13 dedicated cleanrooms
- Facility capacity
Why it mattersPassing this inspection reduces risk to the path ahead for human trials. It proves the company can make the therapy to the strict standards regulators require.
AustraliaThis Australian-developed therapy could eventually offer treatment options for Australians with severe Crohn's disease, a lifelong condition affecting millions worldwide. The milestone shows Australian biotech innovation reaching late-stage development.
