Neurotech International has announced breakthrough results from a clinical trial of its proprietary NTI164 cannabis strain in paediatric Autism Spectrum Disorder (ASD).
The company reported 93% of participants had notable improvements relating to the severity of illness with no serious side effects after 28 days of daily treatment with the strain, which it licenses exclusively from Dolce Cann Global.
Two patients exhibited vast improvement – meaning complete or near remission of all symptoms – while 10 showed decided improvement or partial remission of symptoms.
The Phase I/II trial was conducted at the Monash Children’s Hospital in Melbourne.
Following the positive results, and feedback from parents, the study has been granted approval for the treatment to continue for a further 54 weeks.
Neurotech said the results set the foundation for future studies and pave the way for new treatments for neurological disorders including Attention Deficit Hyperactivity Disorder (ADHD), Multiple Sclerosis, Motor Neurone Disease, Rett Syndrome and Cerebral Palsy.
The next step will be the initiation of Phase II/III of the trial to further assess the long-term safety and efficacy of NTI164, potentially leading to drug registration.
The company is in discussions with the US Food and Drug Administration (FDA) and has initiated pre-Investigational New Drug activities in relation to its US-based operations.
Given the trial showed no serious adverse side effects and high patient compliance, Neurotech said it is “well placed to make significant inroads into the ASD market expected to be worth more than US$5 billion by 2028”.
Chairman Brian Leedman said: “We cannot underestimate the significance of the results from our world-first, landmark trial.
“Neurotech is now a significant step closer in the drug-development timeline to introducing… a treatment option for paediatric ASD which is natural, safe and – based on the results to date – offers substantial behavioural improvements in ASD.”
CEO Dr Alexandra Andrews added: “We are extremely pleased with these breakthrough results. The fact that 93% of participants have shown notable improvements without any serious side effects is an outstanding outcome.
“We are incredibly grateful for the generous participation of patients and their families as well as the team of staff and clinicians at Monash Children’s Hospital who have made this landmark trial possible.
“It is heart-warming to think we may ultimately be in a position to effectively support children with autism and their caregivers by providing a new therapeutic option that may improve their quality of life.”
Chief investigator at Monash Children’s Hospital Professor Michael Fahey said he was very encouraged by the results of the “rigorous study”.
He added: “We are looking forward to the extension of this trial, in addition to the planned initiation of a Phase II/III trial, to further assess the long-term safety and efficacy of NTI164 with the potential to lead to drug registration.”