FDA IND clearance allows Neurotech to start PopPK study in US, complementing Australian Phase 3 trial for NTI164 in autism spectrum disorder.
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The FDA cleared Neurotech International's investigational new drug application for NTI164, allowing the company to start a population pharmacokinetic study in the US for paediatric neurological disorders driven by neuroinflammation.
The clearance gives Neurotech a formal clinical development pathway toward future FDA registration. The company plans to use the PopPK study to generate dose characterisation data that will complement its ongoing Australian Phase 3 trial, called Beyond Harmony, which is testing NTI164 in children with autism spectrum disorder.
NTI164 is a proprietary drug derived from a cannabis strain with low THC and a novel combination of cannabinoids. It is licensed exclusively for neurological applications globally. Preclinical data suggest it modulates neuroinflammatory signalling and immune dysregulation, mechanisms implicated in neurodevelopmental disorders.
Neurotech managing director Anthony Filippis called the IND clearance an important achievement.
The company is also engaging with the Australian Therapeutic Goods Administration to align its US and Australian regulatory strategies. Neurotech expects the Phase 3 results and the PopPK data to form an integrated dataset for future submissions across multiple jurisdictions.
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