NeuroScientific Biopharmaceuticals (ASX:NSB) Appoints CRO for Crohn's Trial

Aditi Sarkar

01 October 2026 02:05 PM AEST

NeuroScientific Biopharmaceuticals (ASX:NSB) Appoints CRO for Crohn's Trial

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Highlights

NeuroScientific has appointed Southern Star Research as contract research organisation for its Phase 2 trial.
The trial targets refractory Crohn's disease and will run across Australia and the United States.
The company is aiming to initiate the trial by the end of 2026.
The therapy platform is based on adult donor bone-marrow stem cells manufactured in Western Australia.

NeuroScientific Biopharmaceuticals Limited (ASX:NSB) has appointed Southern Star Research as the contract research organisation, or CRO, for its planned Phase 2 clinical trial in refractory Crohn's disease. The trial is intended to run across Australia and the United States, and the company is targeting initiation by the end of 2026. The appointment is an operational step that supports the practical delivery of the study, including site selection and logistics. This article outlines the role of the CRO, the StemSmart platform behind the trial and the broader disease context described in the announcement, while noting that the trial has not yet begun.

Southern Star Research and Its Role

A contract research organisation is an external provider that helps sponsors plan and run clinical trials. According to the announcement, Southern Star Research will manage clinical site identification and setup, engage principal investigators and clinicians, and coordinate product logistics for the trial.

The announcement specifies that data and safety management will be sourced separately, so those functions are not included in the Southern Star appointment. Splitting responsibilities in this way is not unusual in clinical development, as sponsors may engage different specialist providers for different parts of a study. The appointment covers sites in both Australia and the United States, which reflects the multi-region approach for the trial. CEO Nathan Smith is named in the announcement as part of the company's leadership. No trial start date beyond the end-of-2026 target has been provided.

The StemSmart Platform

StemSmart is described as the company's patented stem cell platform. It is based on mesenchymal stem cells, or MSCs, taken from adult human donor bone marrow. The product is manufactured at Royal Perth Hospital in Western Australia.

Mesenchymal stem cells are a type of adult stem cell that has been studied in a range of inflammatory and immune-related conditions, which is why they are of interest in Crohn's disease. The announcement refers to early indications from a previous Phase 2 trial that the company says suggest potency, efficacy and safety. These are the company's own characterisations of earlier work, and they are described as early indications. The planned Phase 2 trial is designed to generate further clinical evidence in a defined patient group, and its outcomes cannot be assumed in advance.

Crohn's Disease Context and Timeline

Crohn's disease is a chronic inflammatory bowel condition, and the announcement describes the trial population as refractory, meaning patients whose disease has not responded adequately to existing treatments. The company cites a global Crohn's disease market of approximately US$13 billion, which is context for the size of the therapeutic area rather than a statement about the company's own prospects.

The company has indicated that it is targeting trial initiation by the end of 2026. With the CRO now appointed, the next steps described are site identification, site setup and engagement of investigators across Australia and the United States. Further announcements would be expected to cover regulatory and operational milestones as the trial approaches its start. Until patients are enrolled, there are no new clinical results to report from this study.

Key Takeaways

NeuroScientific's appointment of Southern Star Research is a preparatory step towards a Phase 2 trial of StemSmart in refractory Crohn's disease across Australia and the United States. The CRO will manage site identification and setup, investigator engagement and product logistics, while data and safety management are sourced separately. The company is targeting trial initiation by the end of 2026, and it references early indications from a previous Phase 2 trial that it says suggest potency, efficacy and safety. These are early indications only, and the new trial has yet to start. Readers should follow later announcements for site activation, regulatory updates and enrolment progress.

FAQs

Q: Who is the new CRO for the trial?

A:Southern Star Research has been appointed as the contract research organisation for the Phase 2 trial in refractory Crohn's disease across Australia and the United States.

Q: What will Southern Star Research manage?

A:It will manage clinical site identification and setup, engage principal investigators and clinicians, and coordinate product logistics, while data and safety management will be sourced separately by the company.

Q: What is StemSmart?

A:StemSmart is the company's patented stem cell platform, using mesenchymal stem cells from adult human donor bone marrow, manufactured at Royal Perth Hospital in Western Australia.

Q: When is the trial expected to begin?

A:The company is targeting trial initiation by the end of 2026, although the announcement does not give a more specific start date or enrolment timetable.

Q: What does refractory Crohn's disease mean?

A:Refractory describes disease that has not responded adequately to existing treatments. The announcement cites a global Crohn's disease market of approximately US$13 billion as context for the trial.

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