Neurotech International completes patient recruitment for pioneering autism spectrum disorder trial

Paediatric neurological disorders specialist Neurotech International (ASX: NTI) has successfully completed patient recruitment for a phase II/III clinical trial assessing potential treatments for children with autism spectrum disorder (ASD).

The next phase of the trial will further assess Neurotech’s NTI164 development, a proprietary drug formulation derived from a unique cannabis strain with low tetrahydrocannabinol, or THC.

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

56 patients recruited

For the next stage of testing, Neurotech has recruited 56 patients with a mixture of Level 2 (requiring substantial support) and Level 3 (requiring very substantial support) autism.

The patients have been enrolled at the paediatric neurology unit at Monash Medical Centre in Victoria through the trial’s principal investigator Professor Michael Fahey, head of the paediatric neurology unit and director of neurogenetics.

“We are delighted to have completed recruitment in this world first clinical trial, which seeks to confirm the therapeutic effects of our broad-spectrum cannabinoid therapy NTI164 as shown in a previous clinical trial, with this much larger randomised, double blind, placebo-controlled Phase II/III study,” said Neurotech’s executive director Dr Thomas Duthy.

“With the explosion in autism-associated costs under the Australian National Disability Insurance Scheme, there is an urgent need for new enabling treatments like NTI164, which has been shown to significantly improve adaptive behaviours and socialisation and improve these children’s quality of life while reducing caregiver burden.”

“The results of this trial will inform our discussions with the Therapeutic Goods Administration to understand our pathway to market approval in Australia as our first market opportunity, where the prevalence of autism is estimated at 1 in 50 across the population, representing a 40 fold increase in the last 20 years.”

Randomised clinical trial

The next round of Neurotech’s studies will be undertaken as a randomised, double-blind, placebo-controlled, Phase II/III clinical trial that will recruit patients with ASD to determine the efficacy and safety of NTI164 versus a placebo.

The study comprises an 8-week treatment period, followed by an 8-week open-label maintenance period and then a 2-week wash-out period.

Participants who choose to continue receiving NTI164 beyond the duration of the study may do so for an additional 38 weeks.

Neurotech has already completed a Phase I/II clinical trial into ASD, which demonstrated excellent safety and efficacy results with NTI164 at 28 days, 20 weeks, and 52 weeks of treatment.

Autism in Australia

Recent studies have found that the number of Australians on the autism spectrum is continuing to rise.

In 2022, the Australian Government announced the development of a National Autism Strategy.

The results of an assessment of that strategy are expected to be released in late 2023/early 2024.

The finalised strategy will cover key reform areas including access to services, healthcare, education and employment.