Paediatric neurological disorders specialist Neurotech International (ASX: NTI) has obtained additional promising secondary endpoint data analysis from a Phase II/III NTIASD2 clinical trial for children with Autism Spectrum Disorder (ASD).
The company said the results from the 54-patient randomised, double-blind, placebo-controlled trial are clinically meaningful and statistically significant.
On 17 April 2024 Neurotech reported the results of the NTIASD2 trial which met the primary endpoint of severity of illness improvement versus placebo, along with improvements in key secondary endpoints relating to clinical improvement, adaptive behaviours and socialisation.
The company has now received results of analysis from the eight week measure relating to the child’s change in Anxiety, Depression and Mood Scale (ADAMS) for the NTI164 arm versus placebo. ADAMS was a secondary endpoint of the trial. ADAMS is a caregiver-led scale that is designed to assess mood and anxiety symptoms and is particularly valuable in the autism population.
ADAMS produces a total score and five subscale scores: manic/hyperactive behaviour, depressed mood, social avoidance, general anxiety, and obsessive/compulsive behaviour. The ADAMS scale is useful for identifying mood and anxiety disorders in children with autism, who may have difficulty communicating their emotional states and is used in both clinical and research settings to track changes in symptoms over time and to evaluate the effectiveness of therapies like NTI164.
There was a marked treatment effect of NTI164 versus placebo to week 8 representing a -19.01 score improvement in the ADAMS scale, which is a clinically meaningful difference and statistically significant (p<0.001, 95% confidence interval -25.0, -13.0). In addition, NTI164 treatment resulted in improvements within the depressed mood (p=0.004), social avoidance (p=0.008), general anxiety (p<0.001) and obsessive/compulsive behaviour (p=0.001) subscales. There was no treatment effect of NTI164 on manic/hyperactive behaviour noted (p=0.154).
At commencement of the Phase II/III ASD trial, 62% of patients in the NTI164 arm were receiving treatment for their anxiety/depression and 43% of patients in the placebo arm. Between day 0 and the end of week 8, patients in the placebo arm saw a deterioration of 24% in their ADAMS result (+7.50) and for NTI164, there was a 39% improvement (-19.9) from baseline to the end of week 8.
“Significant improvements seen in these children’s anxiety, mood and depression as measured by ADAMS is consistent with our previous findings in autism and reinforces our confidence in the utility of NTI164 as a chronically administered therapy in autism, where safe and effective therapies are urgently needed,” Dr Thomas Duthy, Executive Director of Neurotech, said.
NTIASD2 was a randomised, double-blind, placebo-controlled, Phase II/III clinical trial that recruited 54 patients with ASD to determine the efficacy and safety of NTI164 versus placebo.
The study comprised an eight-week treatment period followed by an 8-week open-label maintenance period followed by a two-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 two-week down-titration phase at the end of their extension phase.
