Neurotech Clears Key Regulatory Milestone for NTI164 Phase 3 ASD Study
Neurotech International Limited (ASX: NTI) has secured Human Research Ethics Committee approval to commence its pivotal Beyond Harmony Phase 3 clinical study evaluating NTI164 in individuals with Autism Spectrum Disorder (ASD) Levels 2 and 3. The approval enables site activation and participant recruitment to begin across an Australian clinical network, with expansion into the United States planned over time. The Phase 3 study has been structured to generate data suitable for future regulatory submissions to both the Therapeutic Goods Administration in Australia and the US Food and Drug Administration. Trial design has been informed by Neurotech’s earlier ASD studies, which demonstrated statistically significant and clinically meaningful improvements across multiple symptom domains, alongside caregiver-reported quality-of-life benefits. The study will be led by Professor Michael Fahey, supported by co-principal investigators and satellite sites, and will be conducted in accordance with Good Clinical Practice standards. The approval marks a major step in advancing NTI164 toward a potential registration pathway.
Customer Notice:
Nextgen Global Services Pty Ltd trading as Kapitales Research (ABN 89 652 632 561) is a Corporate Authorised Representative (CAR No. 1293674) of Enva Australia Pty Ltd (AFSL 424494). The information contained in this website is general information only. Any advice is general advice only. No consideration has been given or will be given to the individual investment objectives, financial situation or needs of any particular person. The decision to invest or trade and the method selected is a personal decision and involves an inherent level of risk, and you must undertake your own investigations and obtain your own advice regarding the suitability of this product for your circumstances. Please be aware that all trading activity is subject to both profit & loss and may not be suitable for you. The past performance of this product is not and should not be taken as an indication of future performance.
Kapitales Research, Level 13, Suite 1A, 465 Victoria Ave, Chatswood, NSW 2067, Australia | 1800 005 780 | info@kapitales.com.au
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Neurotech Clears Key Regulatory Milestone for NTI164 Phase 3 ASD Study
Neurotech International Limited (ASX: NTI) has secured Human Research Ethics Committee approval to commence its pivotal Beyond Harmony Phase 3 clinical study evaluating NTI164 in individuals with Autism Spectrum Disorder (ASD) Levels 2 and 3. The approval enables site activation and participant recruitment to begin across an Australian clinical network, with expansion into the United States planned over time. The Phase 3 study has been structured to generate data suitable for future regulatory submissions to both the Therapeutic Goods Administration in Australia and the US Food and Drug Administration. Trial design has been informed by Neurotech’s earlier ASD studies, which demonstrated statistically significant and clinically meaningful improvements across multiple symptom domains, alongside caregiver-reported quality-of-life benefits. The study will be led by Professor Michael Fahey, supported by co-principal investigators and satellite sites, and will be conducted in accordance with Good Clinical Practice standards. The approval marks a major step in advancing NTI164 toward a potential registration pathway.
Customer Notice:
Nextgen Global Services Pty Ltd trading as Kapitales Research (ABN 89 652 632 561) is a Corporate Authorised Representative (CAR No. 1293674) of Enva Australia Pty Ltd (AFSL 424494). The information contained in this website is general information only. Any advice is general advice only. No consideration has been given or will be given to the individual investment objectives, financial situation or needs of any particular person. The decision to invest or trade and the method selected is a personal decision and involves an inherent level of risk, and you must undertake your own investigations and obtain your own advice regarding the suitability of this product for your circumstances. Please be aware that all trading activity is subject to both profit & loss and may not be suitable for you. The past performance of this product is not and should not be taken as an indication of future performance.
Kapitales Research, Level 13, Suite 1A, 465 Victoria Ave, Chatswood, NSW 2067, Australia | 1800 005 780 | info@kapitales.com.au