New Scientific Publication of Phase I/II Rett Syndrome Trial
2025-07-07 · Neurotech International Limited · original investi.com.au ↗
ASX Announcement 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 7 July 2025 Neurotech’s Rett Syndrome Clinical Trial Results Published in Renowned Scientific Journal Neurotech International Limited (ASX: NTI) (“Neurotech” or “the Company”), a clinical-stage biopharmaceutical company focused on paediatric neurological disorders, is pleased to announce the publication of its Phase I/II Rett syndrome clinical trial results in the peer-reviewed scientific journal, Journal of Paediatrics and Child Health. The publication, titled "Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) Improves Symptoms of Rett Syndrome: An Open-Label Study," provides detailed results from the open-label clinical trial evaluating NTI164, Neurotech’s novel full-spectrum medicinal cannabis plant extract containing 0.08% Δ-9-tetrahydrocannabinol (THC). The study assessed NTI164's impact across multiple clinical domains relevant to Rett syndrome. Key findings from the study include: NTI164 was well tolerated. Clinical improvements observed across key symptom areas relevant to Rett syndrome. NTI164 demonstrated potential broader therapeutic benefits, including improvements in neurological, behavioural, and functional measures. The authors concluded that the results provide compelling evidence for NTI164 as a potential therapy for Rett Syndrome. The publication further validates the therapeutic approach of NTI164, highlighting its mechanism of action targeting neuroinflammation, glial dysregulation, and synaptic function, reinforcing its prospects for future regulatory advancement. Neurotech’s Managing Director and CEO, Dr Anthony Filippis, said: "This publication in a respected peer-reviewed journal further underscores the scientific and clinical merit of NTI164. It represents an important step forward in our ongoing efforts to provide novel therapeutic options for Rett syndrome and other paediatric neurological conditions." A copy of the publication is available at: https://pubmed.ncbi.nlm.nih.gov/40568811/ Authority This announcement has been authorised for release by Dr Anthony Filippis, Managing Director and CEO. 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 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 clinically meaningful Phase I/II trials in ASD and Paediatric Autoimmune Neuropsychiatric 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. 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.
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