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Phase 2 trial moving towards initiation: NeuroScientific has appointed Southern Star Research to support its planned Phase 2 StemSmart™ trial in refractory Crohn’s disease across Australia and the United States, with trial initiation targeted by the end of CY2026.
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CRO appointment covers core trial execution: Southern Star Research will identify, set up and manage clinical sites, engage clinicians and principal investigators, and coordinate StemSmart™ treatment logistics for enrolled patients.
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Commercial relevance: NSB says the Phase 2 program, together with manufacturing scale-up activities, is intended to establish a foundation for entry into the approximately US$13 billion global Crohn’s disease market.
1 October 2026 – Perth, WA | NeuroScientific Biopharmaceuticals (ASX: NSB) has appointed Australian clinical research organisation Southern Star Research to support its planned Phase 2 trial of StemSmart™ in refractory Crohn’s disease, moving the program towards clinical site start-up in Australia and the United States and targeted trial initiation by the end of CY2026.
The appointment gives Southern Star Research responsibility for identifying, setting up and managing clinical sites in both countries, engaging clinicians and principal investigators, and coordinating the logistics and delivery of StemSmart™ to patients enrolled in the study. NSB is separately engaging organisations to provide data management and safety management services for the trial.
For NSB, the appointment marks an operational step towards moving StemSmart™ into its next planned clinical study. The company is targeting initiation of the Phase 2 trial by the end of CY2026, alongside ongoing manufacturing scale-up activities. NSB says these activities are establishing a foundation for its entry into the approximately US$13 billion global Crohn’s disease market.
Southern Star Research is an Australian-based, independent clinical research organisation providing services across early- and late-stage clinical development for biotechnology, pharmaceutical and medical device companies.
NSB Chief Executive Officer Nathan Smith said:
“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.”
StemSmart™ is derived from adult human donor bone marrow-sourced mesenchymal stem cells and is manufactured using a patented process designed to improve therapeutic activity and clinical response while modulating abnormal immune responses associated with severe and chronic inflammatory conditions. The company says early indications from a previous Phase 2 study in refractory Crohn’s disease suggest the StemSmart™ MSCs are potent, efficacious and safe.
Refractory Crohn’s disease is a severe, treatment-resistant form of the condition and is the current priority application for NSB’s StemSmart™ platform. The planned Phase 2 program is intended to further evaluate safety and preliminary efficacy in refractory and/or fistulising Crohn’s disease.
The immediate focus is now on clinical site identification and start-up, engagement with clinicians and principal investigators, and coordinating treatment logistics ahead of the planned initiation of the Phase 2 trial by the end of CY2026.
About us:
About NeuroScientific Biopharmaceuticals Ltd
NeuroScientific Biopharmaceuticals Limited (ASX: NSB) is a biotechnology company focused on the development of novel therapeutics targeting immune-mediated inflammatory disorders. The Company’s research is centred on modulating pathological immune responses involved in chronic and degenerative conditions, particularly where current therapeutic options demonstrate limited efficacy or durability. NSB applies advanced preclinical and translational strategies to support the development of first-in-class or best-in-class biologics addressing significant unmet clinical need.
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