How Neurotech’s NTI164 Achieves Rapid Absorption with Minimal THC Exposure

Positive Pharmacokinetic Findings

Neurotech International Limited (ASX, NTI) has announced encouraging results from its first-in-human pharmacokinetic (PK) study of NTI164, a proprietary cannabinoid formulation rich in cannabidiolic acid (CBDA). Conducted in healthy adult volunteers, the study demonstrated rapid and predictable absorption of NTI164, with CBDA reaching peak plasma levels within 2 to 4 hours. Importantly, the study confirmed minimal exposure to THC, the psychoactive component of cannabis, underscoring NTI164’s non-intoxicating profile suitable for paediatric use.

Safety and Dosing Implications

The study also revealed no significant accumulation of cannabinoids in the body after repeated dosing over seven days, with steady-state levels achieved by day three. This finding supports a twice-daily dosing regimen that can provide consistent therapeutic coverage without the risk of build-up, a critical consideration for chronic treatment in children. The stable CBDA to CBD plasma ratio of approximately 16, 1 further confirms the chemical and metabolic stability of NTI164, indicating minimal conversion of CBDA to CBD and preserving the intended therapeutic mechanism.

Therapeutic Potential and Regulatory Pathway

These results align with recent independent research from Johns Hopkins University, which highlights CBDA’s direct neuroprotective and anti-inflammatory effects, distinct from CBD alone. Neurotech’s CEO, Dr Anthony Filippis, emphasized that the data validate NTI164’s safety and targeted action, positioning it as a promising disease-modifying therapy for paediatric neurological and inflammatory brain disorders. The company is advancing a dual-track regulatory strategy, preparing submissions for both the US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA), aiming to accelerate global access to this pharmaceutical-grade treatment.

Context Within Neurotech’s Clinical Pipeline

NTI164 builds on Neurotech’s existing clinical progress, including completed Phase II/III trials in Autism Spectrum Disorder and Phase I/II trials in related paediatric neuropsychiatric conditions. The favourable pharmacokinetic and safety profile demonstrated in this study reduces development risk and strengthens the product’s benefit-risk balance, critical for regulatory approval and eventual commercialisation. While the current PK study involved a small cohort of healthy adults, the findings provide a robust foundation for dosing strategies in future paediatric trials.

Overall, Neurotech’s latest data reinforce NTI164’s potential as a safe, effective, and standardised cannabinoid therapy tailored for children with chronic neurological conditions, addressing a significant unmet medical need.