Last Patient Completes Treatment in the Phase II/III ASD...

Last Patient Completes Treatment in the Phase
II/III ASD Clinical Trial
Neurotech International Limited (ASX: NTI) (“Neurotech” or “the Company”), a clinical-stage
biopharmaceutical development company focused predominately on paediatric neurological
disorders, today is pleased to announce the 54th and final patient has completed their last visit (LPLV)
for the Phase II/III NTIASD2 clinical trial for children with Autism Spectrum Disorder (ASD). The trial
recruited patients aged 8-17 (inclusive) with Level 2 (requiring substantial support) and Level 3
(requiring very substantial support) autism, who have now completed eight (8) weeks of daily NTI164
treatment (the randomisation period of the trial). All patients were enrolled at the Paediatric
Neurology Unit at Monash Medical Centre, through the trial’s Principal Investigator Professor Michael
Fahey, Head of the Paediatric Neurology Unit and Director of Neurogenetics.
Dr Thomas Duthy, Executive Director of Neurotech said “We are delighted to have completed the 8
week randomisation phase of 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. 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 in an earlier clinical
trial.”
Dr Duthy continued “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. More recent 2023 data from the NDIS agency
suggests a prevalence rate of 1 in 25 for 7-14-year-olds with a primary diagnosis of autism in Australia,
which is among the highest rate in the world.”
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The results of the NTIASD2 clinical trial are expected in early Q2 CY2024.
NTIASD2 is a randomised, double-blind, placebo-controlled, Phase II/III clinical trial that has recruited
54 patients with ASD to determine the efficacy and safety of NTI164 versus placebo. The study
comprises an 8-week treatment period followed by an 8-week open-label maintenance period
followed by 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. They will undergo the 2-week
down-titration phase at the end of their extension phase.
The primary endpoint of the trial is Clinical Global Impression-Severity (CGI-S), which reflects a
clinician’s impression of severity of illness on a 7-point scale ranging from 1=not at all to 7=among the
most extremely ill. Key Secondary Endpoints include Change in Vineland Adaptive Behaviour Scales,
Third Edition (Vineland™-3), Change in Social Responsiveness Scale, 2nd Edition (SRS-2), Change in
Clinical Global Impression Scale -Improvement (CGI-I), Change in Anxiety, Depression and Mood
Scale (ADAMS) and safety as measured by full blood, liver and kidney analyses at defined time
points