NSB secures CRO partner for Phase 2 StemSmart™ trial in Crohn’s disease
NeuroScientific Biopharmaceuticals Limited (ASX: NSB) has contracted Southern Star Research to manage its planned Phase 2 clinical trial evaluating StemSmart™ in patients with refractory Crohn’s disease across Australia and the United States, with trial initiation targeted by the end of CY2026. The appointment marks a key operational milestone for NSB as it progresses towards entry into the approximately US$13 billion global Crohn’s disease market.
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End of CY2026 trial initiation targeted as Southern Star Research comes on board
Southern Star Research is a full-service, independent, Australian-based CRO that provides comprehensive clinical research services for small to mid-sized biotechnology and pharmaceutical companies across early through late phase clinical development.
Under the engagement, Southern Star Research will be responsible for the identification, set-up, and management of clinical sites in both Australia and the United States. Its responsibilities also include engagement with clinicians and principal investigators, and the logistics and delivery of StemSmart™ to patients enrolled in the trial.
Reflecting the structured approach to trial governance, NSB is engaging separate organisations to conduct data management and safety management services. Trial initiation is targeted by the end of CY2026.
Nathan Smith, Chief Executive Officer
“We are delighted to appoint Southern Star Research to deliver StemSmart™ to patients suffering from treatment-resistant Crohn’s disease. Southern Star Research’s capabilities are a strong fit for our program as we progress towards clinical site start-up and engagement with principal investigators. This appointment is a key operational milestone towards the initiation of the Phase 2 clinical trial by the end of CY2026.”
Understanding refractory Crohn’s disease and why stem cell therapy matters
What is refractory Crohn’s disease?
Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract that can cause severe abdominal pain, diarrhoea, fatigue, and malnutrition. The term “refractory” describes cases in which standard treatments, including biologics and immunosuppressants, have failed to adequately control the disease.
This subset of patients represents a significant unmet clinical need. Existing therapeutic options offer limited efficacy or durability for this population, leaving a large number of individuals without adequate treatment pathways.
How StemSmart™ works
StemSmart™ is derived from adult human donor bone marrow-sourced mesenchymal stem cells (MSCs) and is produced using a patented manufacturing process developed at Royal Perth Hospital, Western Australia. The technology is designed to improve therapeutic activity and clinical response, as well as modulate pathological immune responses commonly associated with severe and chronic inflammatory conditions.
Importantly, this Phase 2 evaluation is not the first clinical exposure for StemSmart™. Early indications from a previous Phase 2 trial in refractory Crohn’s disease suggest StemSmart™ MSCs are “potent, efficacious and safe.” The planned Phase 2 trial is a further evaluation intended to assess safety and preliminary efficacy in refractory and/or fistulising Crohn’s disease, with the goal of making the treatment available to patients for whom current therapies remain inadequate.
Milestone-driven path to a US$13 billion market
The Southern Star Research appointment sits within a broader sequence of operational milestones NSB is progressing towards Phase 2 trial initiation:
- Manufacturing scale-up transfer — advancing, as referenced in NSB’s ASX announcement of 17 March 2026
- Southern Star Research appointment — current milestone, with clinical site start-up activities now underway
- Trial initiation — targeted by the end of CY2026
- Phase 2 data readout — future catalyst (no specific timeline beyond CY2026 initiation has been disclosed)
The table below summarises the key parameters of the planned trial:
| Element | Detail |
|---|---|
| Trial phase | Phase 2 |
| Indication | Refractory Crohn’s disease |
| Geographies | Australia and United States |
| CRO appointed | Southern Star Research |
| Trial initiation target | End of CY2026 |
The dual-geography scope of the trial, spanning Australia and the United States, reflects the scale of NSB’s commercial ambitions for StemSmart™. The global Crohn’s disease market is estimated at approximately US$13 billion, and NSB’s platform is specifically targeting the treatment-resistant segment of that population, where therapeutic alternatives remain limited. With manufacturing scale-up activities already progressed and a CRO now engaged, the company’s foundational infrastructure for Phase 2 trial execution is taking shape.
The StemSmart manufacturing scale-up at Q-Gen Cell Therapeutics in Brisbane entered its first GMP demonstration run phase in March 2026, with the full technology transfer programme on schedule for completion in 2H 2026 ahead of clinical supply requirements.
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