Can you make autistic people less autistic? Neurotech International (ASX: NTI) believes so based on data published from their Phase II/III clinical trial of NTI-164 which aims to treat Autism Spectrum Disorder (ASD).
ASD is a complex neurodevelopmental condition that can manifest in various ways. From challenges in social interactions, repetitive behaviours, and restricted interests, every individual has their own unique set of challenges. Despite the advancements in science, cure for ASD remains elusive. Researchers are constantly exploring different avenues encompassing both medications and therapeutic interventions that can help manage symptoms and improve quality of life for autistic individuals.
Neurotech’s Phase II/III NTIASD2 clinical trial delved deeper into the effects of NTI-164 on two specific patient groups. The first group consisted of children who received NTI-164 for the entire 12-week trial duration. These patients displayed improvement, with their symptoms becoming “barely noticeable” by week 12. This progress was reflected in their Clinical Global Impression – Severity of illness Scale (CGI-S) scores, which improved by 56% from baseline. This shift translates to a transition from being categorised as “markedly ill” at the start of the trial to “borderline ill” by week 12.
The second group comprised patients who initially received a placebo for the first eight weeks of the trial. After eight weeks, these patients were switched to NTI-164 for the remaining four weeks (weeks 9-12). Even with this shorter exposure to NTI-164, these patients also showed 21% improvement in their CGI-S scores. This response suggests that NTI-164’s benefits may take effect quickly.
Dr Thomas Duthy, Executive Director of Neurotech said “We were curious to understand the immediacy of the benefits conferred by NTI-164 in the context of an unblinded clinical trial where patients previously receiving placebo were crossed-over to receive progressively higher amounts of NTI-164 over 4 additional weeks prior to entering the 52 week extension part of the trial.
“The results once again confirm the benefits conferred are drug-related with a rapid clinical onset of improvement. Moreover, patients who have received NTI-164 for 12 weeks in total continued to improve following the primary analysis at 8 weeks, so much so their symptoms are barely noticeable. In general this means substantial lifestyle improvements for the patient and their caregivers, which makes us very proud to be supporting these clinical trials in autism.”
These findings from Neurotech’s NTIASD2 indicate that NTI-164 may offer sustained improvements for children with ASD. The analysis also highlights the drug’s safety profile, with no serious adverse events linked to NTI-164 reported during the trial period.
In April 2024, Neurotech completed a private Placement to institutional investors, raising $10m at an Offer Price of $0.10 per New Share.
NTI has achieved milestones in advancing NTI-164 across other paediatric neurological disorders, demonstrating clinically meaningful results in three conditions also. In June 2024, Neurotech revealed full data from the Phase I/II clinical trial for Rett Syndrome. Furthermore, NTI unveiled metabolic genomic data from the Phase I/II clinical trial for PANDAS/PANS, deepening its commitment to advancing treatments for these neurological conditions.
The March 2024 quarter saw a negative operating cash flow of $1.7 million but the Company had $4.2 million of cash on hand, as of 31 March 2024 and that figure was bolstered by the $10m capital raise in April 2024.
Sidra is a Business Writer with The Sentiment
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