FDA schedules Pre-IND meeting for NSB’s US Crohn’s disease trial
The US Food & Drug Administration (FDA) has confirmed 31 August 2026 as the date for NeuroScientific Biopharmaceuticals (ASX:NSB) Pre-Investigational New Drug (Pre-IND) meeting. The milestone relates to the company’s planned Phase 2 clinical trial targeting refractory Crohn’s disease for patients in the US and Australia, using its StemSmart™ platform.
The scheduled meeting is a critical regulatory step on the path towards an IND application, which NSB intends to submit by late CY2026. It provides an opportunity for the FDA to review the clinical, scientific, and product development of StemSmart™ to ensure suitability for a future IND submission, and helps de-risk the trial design ahead of that submission.
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Why the Pre-IND meeting matters
A Pre-IND meeting is a stage where the FDA reviews the clinical, scientific and product development of a prospective treatment to ensure suitability for a future IND submission. For NSB, this process is intended to confirm that the planned Phase 2 trial design is “suitable for US patients” and of a standard capable of supporting clinical translation.
Outcomes from the meeting are expected to strengthen the company’s ongoing Phase 2 preparatory activities. Key details include:
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Meeting date: 31 August 2026
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Regulator: US Food & Drug Administration (FDA)
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Target indication: refractory Crohn’s disease (US and Australia patients)
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Next milestone: IND application by late CY2026
CEO Commentary
“Our upcoming Pre-IND meeting with the US FDA marks an important milestone in NSB’s clinical development for our patented StemSmart™ technology platform. Interfacing with the FDA on the development of StemSmart at this time is critical to ensuring that the planned clinical trial design is of a standard to support clinical translation of the product. Outcomes from the Pre-IND meeting will strengthen our ongoing Phase 2 clinical trial preparatory activities, which are progressing rapidly as we plan for IND approval by later this year,” said Nathan Smith, Chief Executive Officer.
Understanding StemSmart™ and refractory Crohn’s disease
Refractory Crohn’s disease is a severe, treatment-resistant form of the condition, affecting patients for whom current therapies remain inadequate. This represents a large treatment-resistant population where clinical need is significant.
StemSmart™ is a patented stem cell technology platform derived from adult human donor bone marrow-sourced mesenchymal stem cells (MSCs). It is produced using a patented manufacturing process, developed at Royal Perth Hospital in Western Australia, designed to improve therapeutic activity and clinical response, as well as modulate pathological immune responses often associated with severe and chronic inflammatory conditions.
The platform targets immune-mediated severe inflammatory diseases more broadly, with refractory Crohn’s disease serving as the initial clinical focus. A patented platform addressing unmet need across multiple inflammatory conditions may offer expansion potential beyond the first indication.
| Feature | Detail | Why it matters |
|---|---|---|
| Technology | Patented stem cell technology platform using adult human donor bone marrow-sourced MSCs | Proprietary manufacturing process may support differentiation and future indications |
| Lead indication | Refractory Crohn’s disease (US and Australia) | Large treatment-resistant population with inadequate current therapies |
| Prior evidence | Early indications from a previous Phase 2 trial suggest StemSmart™ MSCs are potent, efficacious and safe | Provides supporting context ahead of the planned trial |
| Regulatory stage | Pre-IND meeting scheduled for 31 August 2026 | Gateway step before IND submission and US Phase 2 trial |
What the milestone means for investors and what’s next
The Pre-IND meeting is the gateway step before the IND submission that would enable the US Phase 2 trial to proceed. Interfacing with the FDA at this stage is intended to align the trial design with regulatory expectations before formal submission.
Prior supporting evidence lends context to the development case. Early indications from a previous Phase 2 trial in refractory Crohn’s disease suggest StemSmart™ MSCs are “potent, efficacious and safe”, per NSB’s 16 April 2025 announcement. This reflects prior, early-stage evidence rather than new trial results.
StemSmart clinical response data from the prior Phase 2 trial showed a 78% clinical response rate and 44% remission in refractory Crohn’s patients who had already exhausted biologic therapies, providing the evidentiary foundation underpinning the planned US and Australian trial program.
The company’s 13 January 2026 announcement, “Successful Clinical Results Achieved under Special Access”, provides additional supporting context around the platform’s clinical progress.
Looking ahead, the roadmap comprises the following steps:
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Pre-IND meeting with the FDA, scheduled for 31 August 2026
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Incorporate FDA feedback into the Phase 2 trial design
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IND application submission, targeted for late CY2026
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Phase 2 clinical trial across the US and Australia, subject to approval
With the Pre-IND meeting date now confirmed, attention turns to the outcomes of that engagement and the targeted IND application by late CY2026. These near-term milestones represent the next verifiable steps in NSB’s clinical development plan for StemSmart™ in refractory Crohn’s disease.
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