NeuroScientific Reports 80% Clinical Response in Crohn’s Disease Patients

Strong Clinical Signals from StemSmart in Fistulising Crohn’s Disease

NeuroScientific Biopharmaceuticals (ASX:NSB) has reported promising results from its StemSmart™ therapy in a small cohort of fistulising Crohn’s disease patients treated under the Therapeutic Goods Administration’s Special Access Scheme. Out of five patients treated, four (80%) achieved a significant clinical response, defined as at least a 50% reduction in fistula openings or discharge, with no serious adverse events recorded. The fifth patient showed a partial response, underscoring the potential of StemSmart™ in a patient group that had exhausted existing treatment options.

The clinical improvements were corroborated by multiple disease activity and quality of life indices, including the Crohn’s Disease Activity Index and Perianal Disease Activity Index, with all patients experiencing removal of at least one seton, a key marker of healing. These outcomes build on earlier Phase 2 data showing a 78% response rate in refractory Crohn’s disease, reinforcing the StemSmart™ platform’s therapeutic promise.

Dual Phase 2 Trials Targeting Crohn’s Disease Launched

Buoyed by these encouraging patient outcomes, NeuroScientific has initiated planning for two Phase 2 clinical trials. The first is an open-label, single-arm study targeting fistulising Crohn’s disease in Australia, designed to leverage the TGA Clinical Trial Notification pathway. Success in this trial could expedite local marketing authorisation and early commercialisation.

The second trial is a randomised, double-blinded study for refractory Crohn’s disease across Australian and US sites, progressing under the US FDA Investigational New Drug program. This trial aims to attract global partners for subsequent Phase 3 development and commercialisation, positioning StemSmart™ for broader market reach.

Manufacturing Transfer to Q-Gen Advances to Critical Validation Phase

On the manufacturing front, the transfer of StemSmart™ production to Q-Gen Cell Therapeutics in Brisbane is progressing on schedule. The project has entered the crucial validation phase, involving GMP engineering and demonstration runs to confirm Q-Gen’s ability to produce StemSmart™ batches meeting potency and release specifications. Completion of this technology transfer and a successful TGA audit are anticipated in the second half of calendar 2026, enabling clinical-scale supply for the Phase 2 trials.

Financial Position and Strategic Asset Decisions

NeuroScientific ended the June quarter with $4.6 million in cash, supporting ongoing clinical development and manufacturing activities. Operating cash outflows totalled $1.055 million for the quarter, primarily directed towards research and development, including $311,000 related to the Q-Gen technology transfer.

Separately, the company announced it will no longer pursue independent development of its EmtinB asset for glaucoma. Instead, NeuroScientific intends to out-license this asset to partners with specialised ophthalmic expertise, aiming to preserve shareholder value while focusing internal resources on StemSmart™.