Neurotech International Limited announced the final clinical results from eleven (11) paediatric Autism Spectrum Disorder (ASD) patients, following daily treatment of NTI164 over a 52 week period. The trial was originally designed as a 28 day study but extended to 52 weeks, and more recently for an additional six months, where Neurotech will collect additional safety data. No further clinical efficacy investigations or analyses are planned.

Clinical Results: Efficacy: Eleven (n=11) paediatric patients remained on daily treatment of NTI164 for the full duration of the 52 week period and were therefore evaluable for the analysis. Their data at this time point (52 weeks) was compared to these same patients' data at baseline, 28 days and 20 weeks. The three patients who discontinued treatment were censored (excluded) from the analysis undertaken (not related to drug effects of NTI164) at 20 weeks onwards.

At 52 weeks of treatment (n=11), the mean severity of illness rating of the CGI-S was 3.0, representing an improvement of 30% from baseline (CGI-S: 4.3). The mean difference between 52 weeks of treatment and baseline was -1.1, 95% Confidence Interval (CI) = -2.08, -0.12, p value=0.032 (28 days: -0.714, 95% CI = -1.332, -0.097, p=0.027; 20 weeks: -1.1, 95% CI = -1.772, -0.3948, p=0.005). The results continue to demonstrate that of the ~40% of subjects markedly or severely ill at baseline - 0% of patients from week 4 onwards were classified as markedly to severely ill.

In addition, these results show a significant improvement in average severity of illness scores over time. At 52 weeks, the patients' adaptive behaviour as measured by the VinelandTM-3 adaptive behaviour scores, was significantly improved overall (mean difference of 6.4; 95% CI = 0.94, 11.81, p value=0.028), and individual domains of communication (mean difference of 6.25; 95% CI = 4.26, 8.24, p value=0.0001), daily living skills (mean difference of 8.5; 95% CI = 3.50, 13.50, p value=0.005), and socialisation (mean difference of 6.5; 95% CI = -2.13, 15.13 p value=0.1181). Adaptive behaviour is an important factor in predicting long-term outcomes for people with ASD and improving this behaviour is a goal of any treatment intervention in ASD.

One patient achieved scores within the normative mean range across all measures at 52 weeks. The Social Responsive Scale, 2nd Edition (SRS-2) is an internationally recognised tool used to identify social impairment associated with ASD and quantifies its severity using a Total score plus six sub-scales (Social Awareness, Social Cognition, Social Communication, Social Motivation, Restricted Interest and Repetitive Behaviour and Social Communication and Interaction). The mean total T-score for the 11 patients after 52 weeks of daily NTI164 treatment was 73.8 which is a significant improvement from baseline where it was 78.7 (mean difference of -4.1, 95% CI = -8.17, -0.033, p value=0.049).

Safety: Across the 20-52 weeks of the trial a total of 6 adverse events were recorded. None of these adverse events were serious and were not considered to significantly interfere with the patient's functioning. Conclusions: NTI164 has shown to be safe and well tolerated up to doses of 20/mg/kg/day.

NTI164 has shown statistically significant efficacy in improving the symptoms associated with ASD after 52 weeks of daily therapy. The side effects reported were not serious or severe and did not significantly interfere with patients' functioning. No clinically significant abnormal laboratory values were reported.

The durability of the clinical efficacy and safety observed at 20 weeks continued through to 52 weeks of treatment, with further improvements noted in gold standard ASD measures, and no additional safety concerns noted. The Company will continue to collect important safety information on patients who have elected to continue to receive daily treatment with NTI164 for an additional six months.