Neurotech International Limited announced the commencement of patient randomisation and the first patient successfully treated under the new Phase II/III NTIASD2 clinical trial for children with Autism Spectrum Disorder (ASD). Recruitment is anticipated to complete in the second half of the calendar year 2023. The trial will be enrolling children at the Paediatric Neurology Unit at Monash Medical Centre.

The Company received HREC approval and Clinical Trial Notification (CTN) scheme clearance by the Therapeutic Goods Administration (TGA) on 17 November 2022. NTIASD2 is a randomised, double-blind, placebo-controlled, Phase II/III clinical trial that will recruit up to 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 (VinelandTM-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.