Neurotech International progressing promising paediatric treatment

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By Colin Hay - 

A unique Australian trial currently being conducted by Neurotech International (ASX: NTI) is looking to make a breakthrough in the treatment of major paediatric neurological disorders.

Speaking at a special seminar today, professor Russell Dale, co-principal investigator for Neurotech’s NTI164 clinical trial, said the studies are investigating the potential for the drug to provide the first ever broad-spectrum cannabinoid therapy to show an effect in treating disorders related to PANDAS and PANS.

Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS), collectively PANDAS/PANS, is a clinical diagnosis given to children who have a dramatically quick onset of neuropsychiatric symptoms including obsessive-compulsive disorder (OCD) and/or restrictive eating.

Children suspected of being affected by PANDAS/PANS may exhibit repetitive tic movements, become moody, irritable/aggressive and anxious and have difficulty with schoolwork.

Professor Dale said that currently the cause of PANS is unknown in the majority of cases. However, the disorder is hypothesised to be triggered by infections, metabolic disturbances, and other inflammatory reactions. PANDAS is considered a subset of PANS.

In late August Neurotech confirmed the successful completion of the last patient/last visit (LPLV) element for the phase I/II clinical trial of NTI164.

That portion of the trial saw 15 paediatric patients complete daily oral treatment with NTI164 over the initial 12 weeks of the trial with 100% of patients continuing to receive treatment under the extension phase (54 weeks) of the trial protocol.

Results of the clinical trial are expected by the end of September.

Substantial clinical interest

Neurotech’s executive director, Dr Thomas Duthy, says there is substantial clinical interest in NTI164 as a treatment for certain paediatric neurological disorders characterised by persistent neuroinflammation.

“Neuroinflammation is well characterised in PANDAS/PANS, where approved drug therapies are lacking and clinical trials are desperately needed. We look forward to reporting the clinical efficacy and safety of NTI164 in these patients over the 12 week study period.”

Professor Dale told the seminar audience that the NTI164 clinical program is progressing well into the extension phase.

He said that it was pleasing that all patients voluntarily elected to move to the extension phase of the trial to 52 weeks of treatment.

According to the professor, there is a major market need for new safe and effective therapies for paediatric autoimmune neuropsychiatric disorders associated with streptococcal infections.

In the United States alone, nearly one in 200 children are diagnosed with PANS and PANDAS.

NTI164 a unique therapy

Neurotech’ proprietary drug formulation NTI164 is derived from a unique cannabis strain with low THC (M<0.3%) and a novel combination of cannabinoids including CBDA, CBC, CBDP, CBDB and CBN.

Pre-clinical studies have demonstrated a potent anti-proliferative, anti-oxidative, anti-inflammatory and neuro-protective effects in human neuronal and microglial cells.

Neurotech is also working on treatments for Rett Syndrome and Cerebral Palsy during CY2023 and is commercialising Mente, the world’s first home therapy that is clinically proven to increase engagement and improve relaxation in autistic children with elevated delta band brain activity.