Neurotech International Granted FDA Clearance for US Paediatric Study of NTI164

Neurotech International (ASX: NTI) has been granted clearance by the US Food and Drug Administration (FDA) in relation to an investigational new drug (IND) submission for lead candidate NTI164 to treat paediatric neurological disorders driven by neuroinflammation.

The clearance allows the company to commence comprehensive population pharmacokinetic (PopPK) study for the drug in the US and establishes a formal clinical development pathway to support future FDA registration.

NTI164 is a proprietary drug formulation derived from a unique cannabis strain with low tetrahydrocannabinol and a novel combination of cannabinoids.

It is being developed as a therapeutic drug product for a range of neurological disorders in children involving neuroinflammation and has been exclusively licenced for neurological applications globally.

Neurodevelopmental Disorders

Preclinical and earlier findings have demonstrated NTI164’s potential to modulate neuroinflammatory signalling, immune dysregulation and upstream biological mechanisms implicated in neurodevelopmental disorders.

The US study will look to complement Neurotech’s Australian Phase 3 “Beyond Harmony” trial, which is designed to generate pivotal efficacy and safety data for NTI164 in paediatric patients with autism spectrum disorder.

Neurotech expects the Phase 3 results to form an important component of a global clinical evidence package supporting future regulatory submissions, while the PopPK study would output vital pharmacokinetic data to support dose characterisation and product registration initiatives.

The intent is for the two combined to generate an integrated dataset to support Neurotech moving forward.

NTI164 Regulatory Milestone

Neurotech managing director Anthony Filippis said FDA clearance of the IND application was an important achievement in the development of NTI164.

“This clearance reflects the progress and maturity of our overall development program,” he said.

“It enables us to commence clinical activities in the US to contribute an integrated clinical and regulatory evidence package for NTI164 and support our global development, registration, and commercialisation strategy.”

Neurotech is engaging with the Australian Therapeutic Goods Administration (TGA) to ensure alignment of its Australian and US regulatory strategies for NTI164.

The company will use its interactions with FDA and TGA to progress a global development pathway including the potential use of clinical data across multiple regulatory jurisdictions.