Neurotech International doses first patient in Phase 3 trial
- Neurotech International dosed the first patient in its Phase 3 "Beyond Harmony" trial for autism spectrum disorder drug candidate NTI164.
- Shares in Neurotech were unchanged at $0.014 following the clinical development announcement.
- The trial aims to evaluate drug efficacy in up to 200 paediatric patients across six Australian sites to support future regulatory registration.
Neurotech International (ASX:NTI) has dosed the first patient in its pivotal Phase 3 "Beyond Harmony" clinical trial evaluating drug candidate NTI164 in up to 200 paediatric patients with Autism Spectrum Disorder.
The trial expands upon the company's prior Phase II/III HARMONY study, which evaluated efficacy, safety, and tolerability in 54 children aged two to 17.
"Dosing the first patient in Beyond Harmony is a significant milestone for Neurotech and marks the commencement of what is an important pivotal study for NTI164 in autism," said Neurotech International Executive Chairman Mark Davies.
The nationwide trial operates across six sites in Victoria, Queensland, New South Wales, Tasmania, and Western Australia using an adaptive design structure.
The company stated that the study is designed to evaluate core behavioural and functional outcomes to support potential regulatory registration.
Following the announcement the Neurotech International share price was unchanged at $0.014.
The biopharmaceutical firm develops broad-spectrum oral cannabinoid treatments primarily targeted at paediatric neurological disorders.
Neurotech is also advancing NTI164 through clinical programmes targeting other conditions, including Rett syndrome and paediatric autoimmune neuropsychiatric disorders.
