Key Facts:
- FDA supports Phase 2 trial design: Positive responses to six of seven questions, including agreement with the proposed trial in treatment-resistant Crohn’s disease.
- No additional non-clinical studies required: The FDA accepted the existing human evidence and StemSmart™ release-testing strategy. Additional testing to address viral contamination controls is being implemented.
- Trial initiation targeted by end of 2026: Preparations continue for Australia and the US, subject to completion of regulatory, manufacturing and operational requirements.
13 October 2026 – Perth, WA | NeuroScientific Biopharmaceuticals (ASX: NSB) has secured US Food and Drug Administration support for the design of its planned Phase 2 StemSmart™ trial in treatment-resistant Crohn’s disease, with the regulator accepting existing human evidence without requiring additional non-clinical studies.
The feedback addresses key clinical and product-testing questions ahead of the company’s planned Investigational New Drug (IND) submission. NeuroScientific is preparing to conduct the trial in Australia and the United States, targeting initiation by the end of 2026.
The FDA responded favourably to six of the seven questions NeuroScientific submitted through its Pre-IND process. Alongside the trial design and existing human data, the agency accepted the company’s proposed release-testing strategy for StemSmart™.
One manufacturing matter remains to be addressed: the control strategy to ensure the product is free from viral contamination. NeuroScientific said it agreed with the FDA’s feedback and was implementing the required testing, with minimal impact expected on its timelines.
For investors, the significance lies in greater clarity on the requirements for the planned US clinical program. The feedback establishes the FDA’s position on several elements of the development package, while identifying the manufacturing testing still required.
Pre-IND meetings allow companies to obtain regulatory guidance on clinical, scientific and product-development plans before submitting an IND application.
StemSmart™ uses mesenchymal stem cells sourced from adult donor bone marrow and produced through a patented manufacturing process. The planned trial will focus on refractory Crohn’s disease, a severe form of the condition that remains resistant to treatment.
NeuroScientific chief executive Nathan Smith said:
“The excellent outcome from our Pre-IND meeting with the US FDA demonstrates the exceptional work the NSB team has done to ensure 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.”
NeuroScientific will continue preparations for the Phase 2 trial and implement the additional manufacturing testing ahead of its planned IND submission. Its target to initiate the trial by the end of 2026 remains subject to completion of regulatory, manufacturing and operational requirements.
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.
Targeting Crohn’s Disease with StemSmart™ Technology
NSB is prioritising the application of its proprietary StemSmart™ technology targeting refractory Crohn’s- a severe and treatment-resistant form of the condition. NSB’s StemSmart™ product is derived from adult human donor bone marrow-sourced MSCs that is produced using a patented manufacturing process developed at Royal Perth Hospital, Western Australia and designed to improve therapeutic activity and clinical response.
The Company is planning Phase 2 clinical trials to further evaluate 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.
