Neurotech International (ASX: NTI) has been granted a pre-IND meeting by the US Food and Drug Administration (FDA) to discuss their chemistry/manufacture/control package, non-clinical requirements and proposed clinical developmental program for NTI164 in Autism Spectrum Disorder (ASD).
The company has conducted a Phase I/II clinical trial in ASD, which has demonstrated excellent safety and efficacy results.
It plans to commence a Phase II/III clinical trial in Q4 CY2022, and to conduct additional Phase I/II trials in PANDAS/PANS and cerebral palsy during CY2023.
NTI164 is a proprietary drug formulation derived from a unique cannabis strain with low THC and a combination of cannabinoids.
Pre-clinical studies have demonstrated anti-proliferative, anti-oxidative, anti-inflammatory and neuro-protective effects.
It is being developed as a therapeutic drug product for a range of neurological disorders in children.
Following the announcement, shares of Neurotech were up 5.97%.