NTI Doses First Patient in Phase 3 Beyond Harmony ASD Study

Key points

• First patient dosed in pivotal Phase 3 Beyond Harmony study for ASD
• Study aims to evaluate efficacy, safety, and tolerability of NTI164
• Up to 200 patients planned for enrolment in adaptive trial design
• Builds on positive results from earlier HARMONY Phase II/III study

Full summary

Neurotech International Limited (ASX: NTI) has dosed the first patient in its pivotal Phase 3 Beyond Harmony clinical study evaluating NTI164 in paediatric patients with Autism Spectrum Disorder (ASD). This marks a significant milestone as the study aims to assess the efficacy, safety, and tolerability of NTI164 in children with ASD. The multi-centre, randomised, double-blind, placebo-controlled study is designed to evaluate key behavioural and functional outcomes. With up to 200 patients planned for enrolment, the study builds on the clinical evidence generated from Neurotech's earlier HARMONY Phase II/III study, which demonstrated positive results.