The Australian Human Research Ethics Committee (HREC) has approved Neurotech International’s expansion of its ongoing Phase II/III clinical trial of NTI164 for autism spectrum disorder (ASD) to adult patients.
With the latest development, the company will now retain subjects who turn 18 years old on NTI164 treatment during the trial’s extension phase.
Dubbed NTIASD2, the double-blind, randomised and controlled-to-open-label study is designed to evaluate the efficacy of up to 20mg/kg per day dose of NTI164 on ASD severity.
It will analyse the treatment in up to 54 subjects aged two to 17 years.
The trial’s primary endpoint is the Clinical Global Impression-Severity (CGI-S), which indicates the clinician’s impression of disease severity on a seven-point scale.
The scale ranges from one point indicating “not at all” while seven points indicate “among the most extremely ill”.
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Previously, the trial received HREC approval for NTI164 to treat paediatric subjects with ASD only.
The NTI164 drug formulation is obtained from a strain of cannabis with low THC and a novel cannabinoid combination that comprises CBDA, CBC, CBDP, CBDB and CBN.
According to data from pre-clinical research, the drug product was shown to provide potent anti-oxidative, anti-proliferative, neuroprotective and anti-inflammatory effects in human neuronal and microglial cells.
NTI164 is in the development to treat various paediatric neurological ailments with neuroinflammation.
Neurotech International executive director Dr Thomas Duthy said: “We are pleased to secure this additional HREC approval for NTI164 in this patient population.
“I am delighted with the progress of this large double-blind, placebo-controlled clinical trial and we remain steadfastly committed to developing NTI164 as a first-line treatment for Level 2-3 patients with autism where the market need for new therapies remains significant.
“Importantly, with recruitment into the trial to complete during the current quarter, we are on track to report results during the first quarter of calendar year 2024 (Q3 FY 2024).”