NTI Begins Autism Clinical Trials for Unique Cannabis Strain
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Neurotech International Ltd (ASX: NTI) has an exclusive license on unique cannabis strains that have high CBD but low THC.
NTI is trying to prove its cannabis strains can be effective in the treatment of ADHD, epilepsy, and autism.
Cannabidiol - or CBD - is the part of the cannabis plant that is the most promising from a medical perspective and is not psychoactive. THC is the psychoactive component of a cannabis plant and anything over 0.3% is classified as a narcotic.
NTI’s strains contain unique cannabinoids, but less than 0.3% THC - which means it's easier to pass through regulatory pathways and bring products to market.
NTI has begun its first clinical trials on children aged between 5 and 17 years with Autism Spectrum Disorder (ASD).
It is early days for NTI, but if the company can clinically prove its genetic strains are effective in the treatment of neurological disorders, it would make NTI a very valuable company.
We invested for this upside.
We like NTI’s assets and now it has reached the Clinical Trial stage. We have seen outsized returns for successful cannabis stocks that can clinically prove effectiveness of cannabis strains.
GW Pharmaceuticals (NASDAQ: GWPH) and Tilray (NASDAQ: TLRY) are the best examples. GW Pharmaceuticals is capped at $6.9BN and Tilray is currently hovering around the $3BN market cap.
NTI is currently capped at $43M (with $3.5M cash at March 31st), and is an early stage, speculative investment - there is no guarantee of success, however the upside is large.
What’s next for NTI ?
There are likely to be several catalysts over the coming weeks and months:
- NTI will release Interim results and study updates throughout the trial.
- NTI is also in discussions with the TGA and relevant regulatory agencies for the therapeutic expansion and registration of its novel full spectrum plants.
- The company’s Mente device will also be assessed in combination with the novel NTI/Dolce medicinal cannabis strains.
The catalyst - Phase I/II Trials Underway
NTI has today taken the first step in clinically proving effectiveness of its cannabis strains.
NTI has started its Phase I/II Clinical Trials - which is a huge milestone for the company.
The Phase I/II Clinical Trials have been designed to assess safety / tolerability as well as efficacy - measured by a reduction in daily seizures, increase in focus and attention span, increase in school attendance, and various other psychological tools.
The trials are fully recruited, with 20 children aged between 5-17 years old who have been diagnosed with Autism Spectrum Disorder (ASD).
This is the world’s first full spectrum medicinal cannabis study in children with autism.
Successful trials could have far reaching effects not only for NTI’s share price, but for the treatment of ASD as well.
Trial details
NTI has started its fully recruited Phase I/II open label clinical study.
Associate Professor Michael Fahey, Head of Paediatric Neurology at Monash Children’s Hospital will supervise this world first study to assess full spectrum medicinal cannabis in children with ASD.
The study will assess dose escalation in children over a four week period and will involve daily administration of NTI / Dolce FEN 164 dissolved in a neutral tasting oil system. Studies have been designed to assess dose escalation, efficacy and four week wash out period (no treatment).
NTI has an exclusive worldwide licence to utilise proprietary cannabis strains from Dolce Cann Global Pty Ltd. NTI will use FEN 164 to assess key behaviours primarily relating to irritability and aggression in ASD kids over a total 16 week period.
The strains are unique in that they contain minimal THC (<0.3%), which may result in a less onerous regulatory pathway to commercialisation (any cannabis strain with a THC level above 0.3% is regulated as a narcotic).
Studies to date have demonstrated that NTI/DOLCE strains have potent neuro anti-inflammatory, neuro-regulatory and neuro-modulatory activities.
Tools that are OECD and WHO validated will be used to assess key patients’ parameters relating to behaviour, attention span, focus span, agitation, irritability and overall quality of life.
What’s next for NTI ?
Beyond today, there are likely to be several catalysts over the coming weeks and months:
- NTI will release Interim results and study updates throughout the trial.
- NTI is also in discussions with the TGA and relevant regulatory agencies for the therapeutic expansion and registration of its novel full spectrum plants.
- The company’s Mente device will also be assessed in combination with the novel NTI/Dolce medicinal cannabis strains.
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