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Q&A on NTI164 Breakthrough Clinical Trial Results in ASD

25/07/22 - Neurotech International Limited (ASX: NTI) recently announced the ground-breaking results with respect to the safety, tolerability, and efficacy of NTI164 and on key behavioural parameters that impact Autism Spectrum Disorder (ASD) patients. NTI164 is one of NTI’s proprietary cannabis strains, exclusively licenced from Dolce Cann Global (Ltd), in respect of neurological applications and is the world’s first full-spectrum medicinal cannabis product (less than 0.3% THC) to be successfully studied in children with ASD.

Conducted by Professor Michael Fahey, Head of Paediatric Neurology at Monash Children’s Hospital in Melbourne, the Phase I/II study was designed to rigorously assess the safety of NTI164 in a dose-escalation regime and to detect signals for efficacy on the behaviour, focus and related cognitive parameters on ASD sufferers using a range of validated neuropsychological tools. The study was also designed to form the foundation for follow-up studies in therapies relating to the treatment of a wide range of neurological disorders such as Attention Deficit Hyperactivity Disorder (ADHD), Multiple Sclerosis, Motor Neuron Disease and Cerebral Palsy.

Following numerous shareholder questions and enquiries on the significance of the results, the Company has put together a summary of key questions and answers with CEO - Dr Alexandra Andrews, Chairman - Brian Leedman and Non-executive Director - Gerald Quigley:

The study showed that 93% of patients showed improvement relating to the severity of illness after 28 days of daily treatment with NTI164 – how do you define ‘improvement’?

Each child was assessed at the start of the trial (before they started treatment with NTI164) to define their own personal ‘baseline’ of symptoms. The average rating for the severity of illness at baseline was 4.4. Across the trial patients this was reduced to 3.6 (on average) after 28 days of NTI164 treatment. The severity of illness is measured using a scale of 1 to 7. Where 1 is defined as “neurotypical, not ill” and 7 defined as “among the most extremely ill”, 4 is defined as “moderately ill” and 3 is defined as “mildly ill”.

64% of children had a global improvement of "much improved”, 29% of children showed "minimally improved" and one child showed "no change". No child showed regression. These results are very encouraging to all families affected by autism.

To put more perspective around these improvements it is important to understand that common symptoms relating to paediatric ASD include anxiety, socialisation problems, aggression, difficulty communicating, lack of attentiveness and focus. Specific examples of significant improvements amongst trial participants included:

  • Marked improvement with school socialisation in terms of attendance and performance regarding speech and learning therapies and classroom behaviour;

  • Previously a number of trial participants were restricted to one-on-one supervision in single purpose rooms whereas NTI164 led patients to be able to participate in mainstream classroom settings for the very first time;

  • Trial participants were able to significantly improve their ability to positively engage and integrate in family and social settings leading to better qualities of life (with no adverse side effects); and

  • Specific instances of participants being far better at following instructions and reading by themselves.

Were there any other key outcomes from the trial?

Yes, some very compelling indicators were received. Two (2/14) patients recorded a Marked Therapeutic Index Score of 2, which is described as “vast improvement” meaning the patients experienced complete or near remission of all symptoms. A further 10 (10/14) patients recorded a Marked Therapeutic Index Score of 5 & 6, representing “decided improvement” meaning the patients experienced partial remission of symptoms.

In terms of measuring the Index Score, the trial involved numerous baseline assessments undertaken by parents, neuropsychologists and clinicians. Both baseline and improvement assessments involved direct and indirect observations and multiple questionnaires. Approximately 2200 assessment points contributed towards the recording of a Trial Index Score.

Read the full announcement Here



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