Australian Biotech Achieves Milestone in Chronic Bowel Disease Treatment
In a significant step forward for Australian medical research, Perth-based NeuroScientific Biopharmaceuticals has successfully treated a fourth patient suffering from severe fistulising Crohn's disease with its innovative StemSmart stem-cell therapy. This milestone advances the company's program targeting the debilitating bowel condition that affects thousands of Australians.
Special Access Scheme Provides Hope for Treatment-Resistant Patients
The groundbreaking treatment is being delivered through the Therapeutic Goods Administration's (TGA) special access scheme, which allows patients with severe, treatment-resistant forms of the disease to receive the unapproved therapy when standard options have failed. For these individuals who have exhausted conventional treatments, StemSmart represents a new beacon of hope.
The therapy utilises a specific type of stem cell known as mesenchymal stem cells (MSC), which are harvested from adult human donor bone marrow. These cells undergo a patented refinement process designed to enhance their therapeutic potency and clinical effectiveness. A key advantage of MSC therapy is that these are universal donor cells, eliminating the need for donor-recipient matching and creating an effective "off-the-shelf" cell therapy solution.
Clinical Progress and Future Applications
NeuroScientific CEO Nathan Smith expressed confidence in the treatment's potential, stating: "We believe StemSmart has the potential to offer a new therapeutic option in an area where there are limited effective treatments." The company's confidence is bolstered by a prior phase two study in refractory Crohn's disease that indicated the therapy was potent, efficacious and safe, along with reports of clinical improvements from compassionate-access patients.
All four patients in this initial treatment cohort are living with an aggressive form of fistulising Crohn's disease. The data generated from their treatments will provide valuable insights for designing NeuroScientific's upcoming phase two trial, scheduled to begin in 2026. This research is expected to strengthen the company's commercial position and pave the way for broader implementation of the therapy.
Looking beyond Crohn's disease, NeuroScientific sees substantial potential for its technology in treating organ transplant rejection, lung inflammation and graft-versus-host disease. Combined, these conditions represent a global market worth tens of billions of dollars. According to company-cited research, the Crohn's disease therapeutics market alone is forecast to reach US$13.8 billion (A$21 billion) by 2026.
The company is preparing to treat additional patients as new doses become available. The first batches will be released from Perth's East Metropolitan Health Service after final quality checks, with production scaling capability through their partner at the Queensland Institute of Medical Research.
Broader Pipeline and Future Outlook
NeuroScientific's product pipeline also includes a protein-based compound called "EmtinB," designed to bind to specific cell receptors and trigger signals that promote healing, nerve growth and reduced inflammation. Modelled on the natural human protein Metallothionein-IIA, EmtinB mimics the body's own defence system and has shown promising results in early tests.
With four patients now undergoing treatment, the first round of clinical results is expected in January 2026. Positive outcomes could propel NeuroScientific into its next major growth phase, transitioning from early access treatments to formalised trials aimed at bringing this new class of stem-cell therapy closer to market availability.
