Neurotech International (ASX:NTI) has announced positive results from its first-in-human pharmacokinetic (PK) study evaluating NTI164, a proprietary CBDA-rich, standardised formulation of cannabinoids.
The study was conducted in healthy adult volunteers to evaluate the absorption, cannabinoid ratios, and systemic exposure profile of NTI164.
The study was conducted in two parts. Part A assessed single-dose pharmacokinetics in four participants who received 20mg/kg/day of NTI164, administered in two divided doses over a single day. Part B examined repeat-dose pharmacokinetics and sex-based dose-exposure dynamics in eight participants dosed twice daily over seven consecutive days.
Blood and urine samples were collected at defined intervals to evaluate CBDA exposure, time to steady-state, accumulation, and cannabinoid stability.
Neurotech said positive results, along with a recent independent study from Johns Hopkins University, support its view that CBDA and other cannabinoids work as active therapies, not just as precursors to CBD.
It states that CBDA acts directly on the body, particularly by targeting inflammation in the brain. Consistent with previous preclinical GLP-compliant toxicology studies in rats and dogs, NTI164 also displayed excellent tolerability with no systemic or organ-specific toxicities or serious adverse events, supporting NTI164's favourable safety profile for chronic paediatric administration.
Neurotech said it is advancing parallel approval pathways in the US and Australia to accelerate global access to NTI164 as a standardised, pharmaceutical-grade treatment for children with neurological and inflammatory brain disorders.
Dr Anthony Filippis, Neurotech CEO and Managing Director, said, "The results of our first-in-human PK study represent another important clinical milestone for NTI164. The clear validation of systemic stability, safety and targeted therapeutic action highlights NTI164's potential as a disease-modifying therapy. We are eager to advance NTI164 rapidly into the next stages of its development and regulatory progress, while actively pursuing commercial opportunities."