Neurotech (ASX:NTI) has today announced the final clinical results from its 11 paediatric Autism Spectrum Disorder (ASD) patients, following daily treatment of NTI164 over a 52-week period.
The results showed strong safety and efficacy effects in the 11 children, with significant improvement across a large number of assessments versus baseline (Day 0).
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.
At 52 weeks of treatment, the mean severity of illness rating of the CGI-S was 3.0, representing an improvement of 30% from baseline.
These results indicate that out of the ~40% of children who were markedly or severely ill at Day 0, none from week 4 onwards were classified as ‘markedly to severely ill’.
At 52 weeks, the patients’ adaptive behaviour as measured by the VinelandTM-3 adaptive behaviour scores was also significantly improved overall.
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 in ASD.
Meanwhile, the Social Responsive Scale had a mean score of 73.8 after 52 weeks, which is a significant improvement from the baseline score of 78.7.
The Social Responsive Scale is used to identify social impairment associated with ASD, which quantifies severity using categories like social awareness, communication, as well as repetitive behaviour and interaction.
“The improvement we have observed in these patients has been impressive, and confirms our earlier findings that NTI164 significantly improves the severity of their illness alongside continued improvements in their socialisation and adaptive behaviour,” said Dr Thomas Duthy, executive director of Neurotech.
“We remain confident our current Phase II/III trial will confirm these important findings in a larger patient population in a randomised, double-blind manner,” he added.
Neurotech says it will now continue to collect safety information on patients who have elected to continue to receive daily treatment with NTI164 for an additional six months.
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