Neurotech International Limited announced the receipt of written Human Research Ethics Committee (HREC) approval and Clinical Trial Notification (CTN) scheme clearance by the Therapeutic Goods Administration (TGA) to commence the Phase I/II clinical trial of NTI164 in children diagnosed with Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute- Onset Neuropsychiatric Syndrome (PANS). In addition to the HREC approval from the Children's Hospital at Westmead, the Company has filed site specific activation documentation to also facilitate the immediate commencement of patient recruitment at the Paediatric Neurology Unit at Monash Medical Centre, under the auspices of Co- Principal investigator Professor Michael Fahey. Recruitment of the 15 patients is anticipated to commence during First Quarter CY2023, with results of the trial anticipated in 2H CY2023.

The Phase I/II clinical trial has been registered on the Australian New Zealand Clinical Trials Registry (ANZCTR).