Neurotech eyes Phase II/III trial and FDA approval after cannabis breakthrough on paediatric autism
Health & Biotech
Health & Biotech
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The recent trial results success could pave the way to test other neurological illnesses, as well as an FDA approval
NTI164 is one of NTI’s proprietary cannabis strains, exclusively licensed from Dolce Cann Global.
It is said to be the world’s first full-spectrum medicinal cannabis product (less than 0.3% THC) to be successfully studied in children with ASD.
The open-label study, conducted at the Monash Children’s Hospital in Melbourne by Professor Michael Fahey, was performed on 14 children aged from eight to seventeen that have a medical diagnosis of Level II and III ASD.
Results were emphatic, with 93% of patients showing improvement relating to the severity of illness after 28 days of daily treatment with NTI164.
64% of the children had a global improvement of “much improved”, 29% of children showed “minimally improved” and one child showed “no change”. Not one child showed regression.
Two out of 14 patients recorded a Marked Therapeutic Index Score of 2, which is described as “vast improvement”, meaning they experienced complete or near remission of all symptoms.
Based on the clinical trial results, NTI164 may now qualify for accelerated registration with the FDA.
This could be either a fast track registration or even potentially an orphan drug status, given the urgent need for treatment options for paediatric ASD.
“We have a clear plan to present to the FDA for registration and approval in the United States, the world’s biggest market for ASD,” said NTI CEO, Dr Alexandra Andrews.
“Our team has been involved with successful FDA applications and registrations in the past, and we are very confident we have the right approach in place for drug registration,” Andrews added.
NTI also plans to commence its landmark Phase II/III drug registration trial in the next quarter.
This trial will include approximately 60 patients based on biostatistical review and analysis.
If all goes to plan, NTI says it will be able to complete the Phase II/III trial by Q3 next calendar year, commence US based clinical trials, and be able to have a registered product for sale within the next two years.
Throughout this period, the company also expects to commence licensing discussions and negotiations with potential big pharma partners.
The latest results also paved the way to test for treatment options for a whole host of other neurological illnesses.
These could include: ADHD, Multiple Sclerosis, Motor Neuron Disease and Alzheimer’s Disease/Dementia – both using NTI164 on its own and in combination with other off-patent drugs.
“We are planning for the commencement of a Phase I/II trials in Cerebral Palsy and Long Covid later this year. These are diseases that currently have very little effective treatment options available,” said Andrews.
The company has already lodged provisional patent applications relating to the composition and use of NTI164 to treat these various neurological disorders, including ASD and ADHD.
NTI164 is derived from a unique genetic strain of medicinal cannabis which naturally contains high levels of CBDA and other minor cannabinoids.
This particular variety expresses very low THC content (less than 0.3%), which allows its use in children.
As such, adverse effects associated with this psychoactive ingredient (notably drowsiness) are not an issue.
NTI164 is also unique because it provides all the beneficial properties and components of ‘full- spectrum’ cannabis without the THC.
Currently, the medical cannabis trend is focusing largely on the efficacy of the “rarer” cannabinoids that go far beyond CBD alone.
“NTI164 contains these rarer cannabinoids which have powerful effects on inflammatory pathways, suppress cytokine activity and work differently to CBD in regulating these complex processes,” said Andrews.
Brian Leedman, chairman of NTI, said NTI164 is a disruptive product that may be the breakthrough needed in treating neurological disorders.
“The potential to develop efficacious treatment with little to no side-effects should be the goal of all biotechnology companies,” Leedman said.
“The results from this breakthrough study make me confident in our success moving forward to later stage clinical studies in ASD and in other neurological indications.
This article was developed in collaboration with Neurotech International, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.