Health · Pharma & Biotech · 8 hrs ago
US FDA supports planned trial of StemSmart therapy for Crohn’s disease
US regulators supported most of the plan for a phase two trial of StemSmart, an experimental cell therapy for treatment-resistant Crohn’s disease.
The therapy is being developed by Perth-based NeuroScientific Biopharmaceuticals and uses cells from adult donor bone marrow.
At a pre-IND meeting, the FDA responded positively to six of the company’s seven questions, backed its trial design and accepted existing human clinical evidence.
The FDA said no additional non-clinical studies were needed, but the company must add testing to check that the product is free from viral contamination.
Crohn’s disease causes long-term gut inflammation, and some patients do not respond to conventional treatment; the planned study will test StemSmart’s safety and early signs of benefit in patients with treatment-resistant and/or fistulising disease.
An earlier study of 18 patients reported a 78 per cent clinical response rate and remission in 44 per cent, but the new trial will provide further evidence.
NeuroScientific aims to begin the trial in Australia and the US by the end of 2026, subject to regulatory, manufacturing and operational requirements.
The US Food and Drug Administration responded positively to six of seven questions about NeuroScientific Biopharmaceuticals’ planned phase two StemSmart trial for treatment-resistant Crohn’s disease.
The FDA backed the proposed trial design and existing clinical evidence, and said no additional non-clinical studies were required.
The company still needs to implement testing to ensure the product is free from viral contamination.
The planned trial will test StemSmart’s safety and preliminary efficacy in patients with refractory and/or fistulising Crohn’s disease.
NeuroScientific aims to start the trial in Australia and the US by the end of 2026, subject to regulatory, manufacturing and operational requirements.
- Who
- NeuroScientific Biopharmaceuticals is developing the therapy. The FDA reviewed its proposed trial.
- What
- The FDA gave positive feedback on the planned phase two trial of StemSmart for Crohn’s disease.
- When
- The FDA response was reported on October 13, 2026. The company aims to start the trial by the end of 2026.
- Where
- The planned trial is in Australia and the US.
- Why
- To test StemSmart’s safety and preliminary efficacy in patients with treatment-resistant and/or fistulising Crohn’s disease.
This story does not have two clearly opposing sides.
A StemSmart study of 18 patients with refractory Crohn’s disease reported a 78 per cent overall clinical response rate and 44 per cent remission rate.
NeuroScientific reported that the FDA responded positively to six of seven questions at a Pre-IND meeting.
The company aims to start the trial in Australia and the US, subject to regulatory, manufacturing and operational requirements.
- FDA response
- Positive responses to six of seven Pre-IND questions
- Earlier study
- 18 patients; 78 per cent overall clinical response rate
- Remission
- 44 per cent of patients in the earlier study
- Planned trial
- Phase two, in Australia and the US
- Target start
- By the end of 2026
What people are saying
The outcome from our Pre-IND meeting with the US FDA demonstrates StemSmart is suitable for use in the planned Phase 2 clinical trial in treatment-resistant Crohn’s disease in the US.
The achievement of another pivotal milestone in NSB’s clinical development for our patented StemSmart™ technology platform takes us one step closer to providing a potential treatment option for patients with this debilitating disease.
Sources
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