Neurotech International poised for autism treatment breakthroughs with NTI164

Clinical-stage biopharmaceutical development company Neurotech International (ASX: NTI) has a number of major developments approaching in 2024 after completing a successful 2023.

In releasing its December quarterly report, Neurotech highlighted the importance of its investigations into the value proposition in Australia for patients with Autism Spectrum Disorder (ASD) and its world-first trial with its NTI164 broad-spectrum cannabinoid therapy.

After appointing a leading health economic consultancy to identify and quantify the value proposition in the December quarter, Neurotech is now awaiting the results of that analysis.

According to Neurotech, previous analysis had found that within the Australian context, early intervention in autism has a material cost saving to the National Disability Insurance Scheme.

The company says that to date such interventions relate largely to occupational therapies, as effective drug therapies for autism are lacking.

However, based on Neurotech’s phase I/II clinical trial evidence for NTI164, the company’s proprietary broad spectrum cannabinoid therapy, a treatment for ASD may be on its way.

NTI164 potential

Results from NTI164 trials generated over 52 weeks, coupled with the pending phase II/III clinical trial results expected in Q1 CY2024, the company believes there is potential for NTI164 to provide a cost-effective, safe, long-term therapy for autism patients.

Neurotech plans to use these results to assist the company in future discussions with government and private payers relating to the appropriate pricing and reimbursement for NTI164.

According to Neurotech, $6.73 billion was paid in government support to people with autism in the year ending 30 June 2023, a 28% increase from the preceding year’s total of $5.27b.

Clinical trial extended

Neurotech recently received Human Research Ethics Committee (HREC) approval to extend the current phase II/III clinical trial to allow for ASD patients who turn 18 years of age to remain on treatment with NTI164 during the extension phase of the trial for up to 54 weeks of total treatment.

The previous HREC approval covered treatment with NTI164 in a paediatric population of ASD, reflecting the inclusion criteria for the current Phase II/III clinical trial (NTIASD2).

The results of the NTIASD2 clinical trial are now expected in the current quarter after Neurotech completed patient recruitment in December.

A total of 56 patients with level 2 (requiring substantial support) and level 3 (requiring very substantial support) autism were enrolled.

Major advance

The company’s world-leading research was again highlighted during the December quarter with a successful clinical trial of NTI164 in paediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS) and paediatric acute-onset neuropsychiatric syndrome (PANS), collectively known as PANDAS/PANS.

In October the company reported statistically significant and clinically meaningful results with the primary endpoints of anxiety/depression and severity of illness met across the 15 patients involved in the trial.

The co-principal investigator of the NTIPANS1 trial, Professor Russell Dale from the University of Sydney and Children’s Hospital at Westmead, said quite profound improvements had been observed in a number of patients dosed with NTI164, making it the first trial of its kind with a broad-spectrum cannabinoid therapy showing initial clinical utility like this with excellent safety.

“In addition, we await further evidence of genomic molecular changes from baseline measures and after 12 weeks of treatment to correlate this meaningful clinical response we have seen with biological evidence of effect,” Professor Dale said.

“This would be a major step-forward for PANDAS/PANS patients and assist in identifying relevant biomarkers of the disease.”

Key outcomes of the trial included significant improvement across a range of gold standard, clinically-validated assessments over 12 weeks of NTI164 treatment.

All patients have now entered the 54-week extension phase of the trial, while the company continues to advance its planned orphan drug designation filings for NTI164 in PANDAS/PANS in the US and Europe.