Neurotech’s cannabinoid drug reports positive results from key study

Neurotech has recorded positive results from the first-in-human pharmacokinetic study of its broad-spectrum cannabinoid drug NTI164

Neurotech reports positive results from PK study of NTI164. Pic via Getty Images.

• Neurotech reports positive results from first-in-human pharmacokinetic study of broad-spectrum cannabinoid drug NTI164

• Study confirms fast, predictable absorption of NTI164, with CBDA as main cannabinoid

• Minimal THC exposure confirms NTI164's non-intoxicating profile, supporting suitability for paediatric use

 

Special Report: Neurotech has received positive results from its first-in-human pharmacokinetic (PK) study evaluating its proprietary broad-spectrum cannabinoid drug NTI164.

Neurotech International (ASX: NTI)said the two-part study was conducted in healthy adult volunteers to evaluate the absorption, cannabinoid ratios and systemic exposure profile of NTI164.

Part A of the PK study assessed single-dose pharmacokinetics in four participants including three male and one female 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, including four male and four female,  dosed twice daily over seven consecutive days.

The males received 20mg/kg/day, while the females received 10mg/kg/day to characterise pharmacokinetic variability and inform future dosing strategies.

Blood and urine samples were collected at defined intervals to evaluate CBDA exposure, time to steady-state, accumulation and cannabinoid stability.

Rapid and predictable absorption of NTI164

NTI164 is being developed as a therapeutic drug product for a range of neurological disorders in children where neuroinflammation is involved.

It is derived from unique cannabis strains with a novel combination of cannabinoids including CBDA, CBC, CBDP, CBDB and CBN.

Neurotech said key findings of the PK study included:

• Rapid, predictable absorption – CBDA reached peak plasma levels up to 3,801 ng/mL within 2–4 hours, demonstrating rapid and predictable systemic absorption.
• Negligible tetrahydrocannabinol (THC) levels – THC exposure remained consistently minimal (≤ 9.5 ng/mL), even at steady-state conditions, affirming NTI164’s non-intoxicating safety profile.
• Stable cannabinoid profile – No significant cannabinoid accumulation was observed, with steady-state conditions achieved by day three and only a modest increase (~17%) seen after multiple doses, indicating no accelerated build-up of cannabinoids in the body.

Neurotech said this was a key finding from both a safety and patient dosing perspective, as it suggested a low risk of long-term accumulation and supported predictable, consistent dosing without the need for complex titration.

• Consistent dosing regimen: Twice-daily (BID) dosing provided effective 24-hour therapeutic coverage, ideal for paediatric management.
• Chemical and metabolic stability: NTI164 showed a stable CBDA:CBD plasma ratio of around 16:1, indicating minimal conversion of CBDA into CBD in the body. Neurotech said this confirmed that CBDA stayed in its original form, supporting both the chemical stability of NTI164 and its intended therapeutic effect.

Strengthens NTI164’s benefit-risk profile

Neurotech said results formed a robust PK data package that justified dose selection and strengthened the product's benefit-risk profile — all essential for achieving positive regulatory outcomes.

The company said the latest results, along with a recent independent study from Johns Hopkins University, supported its view that CBDA and other cannabinoids worked as active therapies — not just as precursors to CBD.

Neurotech said CBDA acted directly on the body, especially by targeting inflammation in the brain.

The company said NTI164, a pharmaceutically standardised formulation, exhibited distinct neuroprotective and anti-inflammatory activity mediated via TRPV1 and 5-HT1A receptors, unlike CBD alone.

Consistent with previous preclinical GLP-compliant toxicology studies in rats and dogs, Neurotech said NTI164 displayed excellent tolerability with no systemic or organ-specific toxicities or serious adverse events, supporting NTI164's favourable safety profile for chronic paediatric administration.

The company said the positive results reduced the risk in NTI164’s clinical development and supported its progression into future registration trials under both the US Food and Drug Administration (FDA) and Therapeutic Goods Administration (TGA) guidelines.

Neurotech 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.

The company said the PK study data would form a component of the regulatory submissions and safety packages being prepared for both agencies.

Another important clinical milestone

CEO and managing director Dr Anthony Filippis said the PK study results were significant for the company as it looks to treat brain inflammation in children with neurological disorders.

"The results of our first-in-human PK study represent another important clinical milestone for NTI164,” he said.

“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."

This article was developed in collaboration with Neurotech International,  a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.