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Neurotech International Limited (ASX:NTI)

ALERT: Price-sensitive ASX Announcement for NTI
Current share price for NTI : $0.019 0.005 (35.71%)+
Announcement
Release
21 Sep 2026 8:51AM
Price at Release
$0.014
Full Release
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Summary
Neurotech International Limited announced that the first patient has been dosed in its pivotal Phase 3 “Beyond Harmony” clinical study of NTI164 for paediatric Autism Spectrum Disorder, marking the formal commencement of the trial and advancement of NTI164 toward potential regulatory registration and commercialisation for the core symptoms of ASD. The national Australian multi-centre, randomised, double-blind, placebo-controlled study is being conducted across six sites in Victoria, Queensland, New South Wales, Tasmania and Western Australia, with up to 200 patients planned under an adaptive design to evaluate efficacy, safety and tolerability, while focusing on behavioural and functional outcomes and neuroinflammatory pathways associated with ASD. The company said the trial builds on encouraging results from its earlier 54-patient HARMONY Phase II/III study, which delivered clinically meaningful and statistically significant results across validated measures with an excellent safety profile, supported Neurotech’s cleared US FDA IND application, and was published in Neurotherapeutics following peer review; Neurotech also highlighted strong community interest in the new trial, with more than 300 enquiries from parents and caregivers, and reiterated the significant unmet need in ASD given the lack of established medications for core behavioural symptoms.
Key Points
  • Neurotech dosed the first patient in its pivotal Phase 3 Beyond Harmony study of NTI164 in children with Autism Spectrum Disorder.
  • The Beyond Harmony trial is a national Australian multi-centre, randomised, double-blind, placebo-controlled Phase 3 study across six sites.
  • The study plans to enrol up to 200 patients under an adaptive trial design.
  • The trial is designed to evaluate the efficacy, safety and tolerability of NTI164 and assess behavioural and functional outcomes relevant to ASD.
  • Neurotech said Beyond Harmony builds on results from its earlier 54-patient HARMONY Phase II/III study.
  • The HARMONY study showed clinically meaningful and statistically significant results across validated measures with an excellent safety profile.
  • HARMONY data supported Neurotech’s cleared US FDA Investigational New Drug application and were published in Neurotherapeutics after peer review.
  • The company reported more than 300 enquiries from parents and caregivers following media coverage of the upcoming trial.
  • Neurotech emphasised the significant unmet need in ASD, noting there are no established medications for the core behavioural symptoms.
  • NTI164 is described as a proprietary GMP-grade standardised formulation containing CBDA-rich extracts and select minor cannabinoids.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.