Neurotech International’s innovative autism spectrum disorder treatment receives 52-week trial extension

Clinical-stage biopharmaceutical development company Neurotech International (ASX: NTI) has received a 52-week extension to its trial of a potential medicinal cannabis plant extract treatment for children with autism spectrum disorder (ASD).

Approval from the human research ethics committee was based on requests from the company’s lead investigator, patients and their caregivers to continue to extend the duration of treatment.

Chief investigator, head of the Paediatric Neurology Unit at Monash Medical Centre and director of Neurogenetics professor Michael Fahey, said receipt of the further extension highlights the progress the trials have made to date.

“This second long-term extension to the core clinical program, which commenced in mid-2022 and reported 52-week safety and efficacy data in March 2023, reflects the significant progress my patients have made and their caregivers’ strong desire to continue treatment over the long term,” professor Fahey said.

“The lack of side-effects with NTI164 and the significant clinical improvements we’ve observed in these patients necessitates a long-term treatment plan.”

“We thank Neurotech for their continued support of our early study patients and we look forward to the results of our larger double-blind, placebo-controlled Phase II/III clinical trial in ASD.”

Executive director Dr Thomas Duthy said Neurotech continues to focus its resources on completing the current Phase II/III ASD trial, while remaining on track to report the results of the Phase II/III ASD trial in late Q1 CY2024 to early Q2 CY2024.

Previous trial success

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

The Phase I/II ASD clinical trial was an open-label study to evaluate the safety and efficacy of orally-administered full-spectrum medicinal cannabis plant extract 0.08% THC (NTI164) in children with ASD.

The company then commenced the Phase II/III randomised clinical trial in ASD in Q4 CY2022.

ASD impact

Autism is a neurodevelopmental disability that affects the way people communicate, process information and interact with the world, while ASD is a term used to describe a condition that presents in a wide range of ways, according to age and a child’s other abilities.

Around 1-2 in 100 Australians suffer from autism and many people will have a connection with an autistic person.

A child with ASD usually has difficulties in two main areas: social communication and repetitive behaviour.

The Autism Cooperative Research Centre has estimated that the average family cost of ASD to be $34,900 per annum, with almost 90% of this due to loss of income from employment.

Each additional symptom reported adds approximately $1,400pa in costs for the family.