Neurotech’s ground-breaking study of cannabis in children on the spectrum progresses
Health & Biotech
Health & Biotech
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Neurotech is anticipating results from its extended world first study of a medicinal cannabis product in children which could be a game-changer in autism treatment.
Clinical-stage biopharmaceutical company focused predominantly on pediatric neurological disorders Neurotech International (ASX:NTI) has provided a positive update on the open-label extension of its Phase I/II clinical trial in children with Autism Spectrum Disorder (ASD).
NTI released promising results from the trial in July with respect to the safety, tolerability, and efficacy of its proprietary NTI164 cannabis strain in ASD.
After 28 days of treatment with NTI164, 93% of patients showed symptom improvement relating to the severity of illness.
In addition, NTI164 was well-tolerated with no serious adverse events recorded across all doses tested (5, 10, 15 and 20 mg/kg/day) and no changes were noted in blood analysis or liver function tests.
NTI164 is one of NTI’s proprietary cannabis strains, exclusively licensed from Dolce Cann Global, in respect of neurological applications.
It is the world’s first full-spectrum medicinal cannabis product (less than 0.3% THC) to be successfully studied in children with ASD.
The Phase I/II trial is being conducted under the guidance of Professor Michael Fahey, Head of Paediatric Neurology at Monash Children’s Hospital in Melbourne.
Lack of any safety issues coupled with positive therapeutic effects of NTI164 across a range of behaviour, focus and related cognitive parameters using validated neuro-psychological tools was good news for the company.
The results meant the trial was granted Human Research Ethics Committee (HREC) approval to continue for a further 54 weeks with additional safety and efficacy assessments over that time.
ASD patients continue to receive daily doses of NTI164, up to a maximum of 54 weeks, with further safety and efficacy data analysis conducted after 20 weeks of daily treatment.
NTI said 20-week data analysis is expected in late Q3 to early Q4 CY2022. In addition, Neurotech expects to report additional analysis between 28 days and 20 weeks on patients using the Vineland-3 outcome measure, which was a secondary endpoint of the study.
Vineland-3 is internationally recognised as a leading instrument for supporting the diagnosis of intellectual and developmental disabilities in ASD, specifically adaptive behaviour.
Adaptive functioning – which encompasses skills people need to function independently at home, at school and in the community – is an important factor in predicting long-term outcomes for people with ASD. Improving adaptive abilities in patients is therefore a desirable treatment goal.
NTI executive director Dr Thomas Duthy said the company was eagerly anticipating the consolidated results at 20 weeks for those patients who continued to receive daily treatment with NTI164 and remain part of the open-label extension of the trial.
“This data will provide deeper clinical insights into longer term treatment with NTI164, where patients are receiving their individualised maximum tolerated dose for a significantly longer period than the sequential weekly treatments of escalating concentrations of NTI164 to the primary outcome measures established at just 28 days of treatment,” he said.
“Such data will be a key module in our future submissions with government regulators including the Therapeutic Drug Administration in Australia and the US Food and Drug Administration to potentially undertake a trial in the US under an Investigational New Drug application.”
This article was developed in collaboration with Neurotech International, a Stockhead advertiser at the time of publishing.
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