drugset / Press release

New Scientific Publication of Phase I/II Autism Trial

2025-03-24 · Neurotech International Limited · original investi.com.au ↗

ASX Announcement 24 March 2025 Neurotech International Ltd Suite 5 CPC, 145 Stirling Highway Nedlands, Western Australia 6009 T: +61 (8) 9389 3130 E: [email protected] W: neurotechinternational.com ABN: 73 610 205 402 ASX: NTI 1 of 2 Neurotech Phase I/II Autism Clinical Trial Published in Leading Scientific Journal Neurotech International Limited (ASX: NTI) (‘Neurotech’, ’ NTI’ or ‘the Company ’) a clinical-stage biopharmaceutical development company focused predominately on paediatric neurological disorders, today announces the publication of the Phase I/II autism spectrum disorder (ASD) clinical trial results in the scientific journal Advances in Complimentary and Alternative Medicine (ACAM). Dr Anthony Filippis, Chief Executive Officer & Managing Director of Neurotech said “This is the second peer reviewed publication on our pre -clinical and clinical results for NTI164 in ASD , with further clinical publications planned or in progress for ASD, PANDAS/PANS and Rett Syndrome. The peer-review process represents an important step in building out the scientific evidence for our programs and improving patient safety and health outcomes over the longer term with our novel treatment approach.” The publication is titled “Safety and Efficacy of Orally Administered Full -spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) in Children with Autism Spectrum Disorder” led by Professor Michael Fahey, Principal Investigator of the Phase I/II clinical trial, from the School Clinical Sciences, Monash Medical Centre. The authors concluded “This open-label study provides preliminary safety and efficacy data on a novel botanical formulation of phytocannabinoids in the treatment of symptoms in children and young people with ASD and associated comorbidities. Results indicate that NTI164 is safe and well-tolerated in this population, with significant efficacy in improving disruptive behaviours and reducing anxiety in these paediatric patients.” The Pha se I/II open-label study assessed the safety and efficacy of Neurotech’s broad spectrum cannabinoid drug therapy NTI164 in treating 14 children and young people with ASD symptoms over 4 weeks of daily treatment. The primary endpoint was to evaluate the safety and tolerance of NTI164 . Currently, 11 patients remain on active NTI164 treatment representing a treatment duration of over 150 weeks. A copy of the publication is available at: https://crimsonpublishers.com/acam/pdf/ACAM.000693.pdf Authority This announcement has been authorised for release by the Board of Neurotech International Limited. For further information contact us via [email protected] About Neurotech Neurotech International Limited (ASX:NTI) ) is a clinical -stage biopharmaceutical development company focused predominately 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 measures and excellent safety. In addition, Neurotech has completed and reported statistically significant and clinically meaningful Phase I/II trials in ASD and Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) a nd Paediatric Acute -Onset Neuropsychiatric Syndrome Neurotech International Ltd Suite 5 CPC, 145 Stirling Highway Nedlands, Western Australia 6009 T: +61 (8) 9389 3130 E: [email protected] W: neurotechinternational.com ABN: 73 610 205 402 ASX: NTI 2 of 2 (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. About NTI164 NTI164 is a proprietary drug formulation derived from unique cannabis strains with a novel combination of cannabinoids including CBDA, CBC, CBDP, CBDB and CBN. Clinical studies have demonstrated a potent anti -proliferative, anti -oxidative, anti -inflammatory and neuro -protective effects in human neuronal and microglial cells. NTI164 is being developed as a therapeutic drug product for a range of neurological disorders in children where neuroinflammation is involved. About the Phase I/II ASD Clinical Trial The clinical trial was a Phase I/II Open -Label Study to Evaluate the Safety and Efficacy of Orally Administered Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) in Children with Autism Spectrum Disorder (ASD). For more information on the trial, please visit www.clinicaltrials.gov Identifier NCT05516407 or the Australian New Zealand Clinical Trials Registry (ANZCTR) under Registration Number: ACTRN12621000760875.

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