Neurotech initiates NTI164 Authorised Prescriber Program
2025-09-23 · Neurotech International Limited · original investi.com.au ↗
ASX Announcement Neurotech International Ltd Suite 102 / Level 1, 55 Collins Street, Melbourne, VIC 3000 T: 03 9498 3132 E: [email protected] W: neurotechinternational.com ABN: 73 610 205 402 ASX: NTI 1 of 2 23 September 2025 Neurotech initiates NTI164 Authorised Prescriber Program Highlights • NTI commences Authorised Prescriber (AP) program for NTI164 in neurodevelopmental disorders • AP Program for NTI164, will be managed by leading paediatric neurologist • Enables controlled, specialist-led access to NTI164 for eligible patients in Australia • Given patient and family demand for NTI164, the program provides a pathway for access • The program will provide valuable real-world data generation to further support the registration pathway • Program structured to be self-funding, with pricing set to cover costs plus a modest margin • Positions NTI164 within the evolving policy environment, including upcoming NDIS reforms Neurotech International Limited (ASX: NTI) (“Neurotech” or “the Company”) , a clinical -stage biopharmaceutical company focused on paediatric neurological disorders, is pleased to announce the commencement of an Authorised Prescriber (AP) program for its therapy NTI164, across a range of neurodevelopmental conditions for paediatric patients in Australia. The program will be managed by leading paediatric neurologist Professor Michael Fahey , Head of Paediatric Neurology Unit, Monash Medical Centre , ensuring strong clinical oversight and structured implementation nationally. This initiative follows increasing demand from patients and their families seeking access to NTI164, with limited capacity available within the Company’s current clinical trials. The AP program provides an immediate, controlled pathway for eligible patients to access NTI164 under specialist supervision, while maintaining the highest standards of patient care. A central objective of the program is the generation of real -world clinical data on NTI164, which will complement the Company’s ongoing and planned clinical and registration trials. These data will provide further evidence of NTI164’s safety and eff icacy across a broader patient population and strengthen Neurotech’s regulatory submissions, advocacy efforts and partnering discussions. Importantly, the AP program establishes early adoption and market presence for NTI164 ahead of pivotal clinical trials and potential registration. The A P program has been designed to ensure patient access while being cost -neutral to the Company. Pricing has been set at a level that covers the cost of supply in addition to a modest margin. This structure allows the program to fund itself while generating valuable real-world data, without being positioned as a material revenue driver for the Company. The launch of the AP program comes following recently announced changes to the NDIS, which will see children with mild to moderate autism spectrum disorder (ASD) diverted off the NDIS and into a newly established program by mid -2027. Neurotech’s AP -driven real -world dataset is intended to position NTI164 appropriately within this new landscape, supporting future regulatory and commercial decision-making. Dr Anthony Filippis, Chief Executive Officer and Managing Director of Neurotech, said: “The launch of the Authorised Prescriber program for NTI164 marks an important step forward in our commercial access strategy. The program reflects the strong demand we are seeing from patients and their families and enables controlled, specialist-led access to NTI164 ahead of pivotal clinical trials and potential registration. Neurotech International Ltd Suite 102 / Level 1, 55 Collins Street, Melbourne, VIC 3000 T: 03 9498 3132 E: [email protected] W: neurotechinternational.com ABN: 73 610 205 402 ASX: NTI 2 of 2 Importantly, it also generates valuable data that will strengthen our submissions to regulatory agencies and aid ou r discussions with potential partners. We remain focused on putting patients and their families at the centre of everything we do, and this program provides a scalable pathway to deliver NTI164 to those who need it most.” Professor Fahey, Principal Investigator of Neurotech’s ASD HARMONY Phase II/III clinical trial said: “I am very pleased to support the launch of the Authorised Prescriber program for NTI164. This initiative represents an important opportunity to provide controlled access to a therapy that has shown encouraging potential in children with significant neurological conditions. For many families, there are very limited treatment options available, and the ability to access NTI164 through the AP pathway ensures that more patients can receive care under specialist supervision .” For further information contact us via [email protected] About Neurotech Neurotech International Limited (ASX:NTI) is a clinical -stage biopharmaceutical development company focused predomina ntly on paediatric neurological disorders with a broad -spectrum oral cannabinoid drug therapy called NTI164. Neurotech has completed a Phase II/III randomised, double- blind, placebo-controlled clinical trial in Autism Spectrum Disorder (ASD) with clinically meaningful and statistically significant benefits reported across a number of clinically -validated measur es and excellent safety. In addition, Neurotech has completed and reported statistically significant and clinically meaningful Phase I/II trials in ASD and Paediatric Autoimmune Neuropsychia tric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute -Onset Neuropsychiatric Syndrome (PANS), collectively PANDAS/PANS along with Rett Syndrome. Neurotech has received human ethics committee clearance for a Phase I/II clinical trial in spastic cerebral palsy. For more information about Neurotech please visit http://www.neurotechinternational.com.
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