Neurotech reports additional positive secondary endpoint data analysis from Phase 2/3 trial of NTI164 in autism patients
NTI164 shows a marked improvement in ADAMS, a caregiver-led scale to assess mood and anxiety symptoms
Approximately 40-50% of children with autism experience clinically significant levels of anxiety.
Special Report: Neurotech is up ~8% today after reporting additional positive secondary endpoint data analysis from its Phase 2/3 trial of autism spectrum disorder paediatric patients participating in its world-first broad-spectrum cannabinoid drug therapy NTI164.
Neurotech International (ASX:NTI) has reported a marked improvement from the eight-week measure relating to the child’s change in Anxiety, Depression and Mood Scale (ADAMS) for the NTI164 arm versus placebo, which was a secondary endpoint of the trial.
The secondary endpoint data analysis follows release of clinically meaningful and statistically significant results from the 54-patient randomised, double-blind, placebo-controlled Phase 2/3 NTIASD2 clinical trial for children with ASD.
NTI says ADAMS is a caregiver-led scale designed to assess mood and anxiety symptoms and is particularly valuable in the autism population.
ADAMS produces a total score and five subscale scores including:
Manic/hyperactive behaviour
Depressed mood
Social avoidance
General anxiety
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.
It is used in both clinical and research settings to track changes in symptoms over time and to evaluate the effectiveness of therapies like NTI164.
Approximately 40-50% of children with autism experience clinically significant levels of anxiety.
The prevalence of depression in autistic children has been estimated at 10-20%.
Marked improvement in Adams scale
NTI says there was a marked treatment effect of NTI164 versus placebo to week eight, representing a -19.01 score improvement in the ADAMS scale, which is a clinically meaningful difference and statistically significant.
Additionally, NTI164 treatment resulted in improvements within the depressed mood, social avoidance, general anxiety and obsessive/compulsive behaviour subscales. There was no treatment effect of NTI164 on manic/hyperactive behaviour noted.
NTI says at the start of the Phase 2/3 ASD trial, 62% of patients in the NTI164 arm were receiving treatment for their anxiety/depression, compared to 43% of patients in the placebo arm.
Between day zero and the end of week eight, patients in the placebo arm saw a deterioration of 24% in their ADAMS result (+7.50), while patients in the NTI164 arm experienced a 39% improvement (-19.9) from baseline to the end of week eight.
NTIASD2 was a randomised, double-blind, placebo-controlled, Phase 2/3 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 eight-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.
Trial meets primary endpoint
In April NTI reported that the Phase 2/3 NTIASD2 trial 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.
In June NTI announced a further analysis had been carried out on the effect of NTI164 in children who were receiving placebo for the first eight weeks of the trial and then crossed-over to the drug from the start of week nine to week 12 per the trial protocol.
In addition, Clinical Global Impression – Severity of illness Scale (CGI-S) information was analysed at week 12 for those patients who were initially enrolled in the NTI164 arm of the trial.
NTI says patients showed a 56% improvement in CGI-S score from baseline at week 12, while patients unblinded at the end of week eight showed 21% improvement in CGI-S score to week 12.
“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,” NTI executive director Dr Thomas Duthy says.
This article was developed in collaboration with Neurotech International, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
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