Neurotech International Limited announced Human Research Ethics Committee (HREC) approval has been secured to extend the Phase I/II Autism Spectrum Disorder (ASD) clinical trial (NTIASD1) beyond the 54 weeks of daily oral treatment with NTI164 for an additional six months on a patient specific basis. The additional submission was predicated on Neurotech's commitment to the paediatric patients who have been recruited into the study and the strong desire of the Paediatric Neurology Unit at Monash Medical Centre, the trial's Principal Investigator Professor Michael Fahey and the family/caregiver's request for a continuation of treatment. Based on the approved HREC extension, individual patients can continue to receive NTI164 for an additional six months over the 54 week treatment period.

This represents a total of 80 weeks or 1.5 years of daily NTI164 treatment, which will generate a substantial amount of additional safety data for Neurotech and enhance future regulatory submissions for additional trials in ASD or alternative paediatric neurological disorders including PANDAS/PANS 1 and cerebral palsy.