Miro Sciences Completes TGA Inspection of StemSmart Manufacturer
Miro Sciences Limited (ASX: MSX), formerly known as NeuroScientific Biopharmaceuticals Limited, is an Australian clinical-stage biotechnology company headquartered in Perth, Western Australia. Listed on the Australian Securities Exchange under the ticker MSX, the company specializes in developing novel therapeutic treatments for immune-mediated inflammatory and degenerative diseases. Its research and clinical development efforts focus on addressing complex conditions where existing therapeutic options demonstrate limited efficacy or durability.
The company’s lead asset is StemSmart™, an advanced cell therapy platform designed to modulate pathological immune responses in patients with severe inflammatory conditions. Miro Sciences is preparing to initiate Phase 2 clinical trials for refractory Crohn’s disease in Australia and the United States in partnership with contract research organization Southern Star Research. Manufacturing technology for StemSmart™ is transferred to Australia-based Q-Gen Cell Therapeutics under Good Manufacturing Practice guidelines to support upcoming clinical evaluation and regulatory oversight by the Therapeutic Goods Administration.
Miro Sciences positions itself as an innovative developer of first-in-class biologics targeting multi-billion-dollar global markets across gastrointestinal, renal, and pulmonary immune-mediated indications. The company’s strategic focus centers on securing regulatory progress, having received positive pre-IND feedback from the US Food and Drug Administration confirming its Phase 2 trial design without requiring additional non-clinical studies. Through strategic clinical partnerships and rigorous translational research, Miro Sciences aims to deliver durable, high-value therapeutic solutions for substantial unmet global medical needs.