Neurotech International (ASX:NTI), has attained a new milestone in its clinical trial for Autism Spectrum Disorder (ASD) – as it now confirms its 54th and final patient has completed their last visit for the Phase II/III NTIASD2 clinical trial.
The trial, conducted at the Paediatric Neurology unit at Monash Medical Centre under the supervision of Professor Michael Fahey, aimed to assess the efficacy and safety of NTI164, a potential treatment for ASD.
Patients aged 8-17 with Level 2 or Level 3 autism received eight weeks of daily NTI164 treatment during the randomisation period of the trial.
The Phase II/III NTIASD2 clinical trial is a randomised, double-blind, placebo-controlled trial involving 54 ASD patients. After the initial treatment period, participants entered an 8-week open-label maintenance phase followed by a 2-week wash-out period. Patients who opted to continue NTI164 treatment beyond the study duration could do so for an additional 38 weeks, with a gradual reduction in dosage at the end.
The primary endpoint of the trial is the Clinical Global Impression-Severity (CGI-S) scale, which assesses the severity of illness. Key secondary endpoints include changes in adaptive behavior, social responsiveness, clinical improvement, and mood, as well as safety assessments through blood and organ analyses.
“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,” Executive Director of Neurotech Dr Thomas Duthy said.
The results of the NTIASD2 clinical trial are anticipated in early Q2 CY2024.
NTI has been trading at 10.5 cents.
