The company’s preparations over the last quarter means that it is now ready to conduct Phase I and II studies on its medicinal cannabis for autistic children.

Neurotech International (ASX:NTI) has released an update on its quarterly activities, which saw the company make significant progress in its efforts to launch a new commercial drug for children with autism.

During the quarter, the company has made progress to commence the world’s first clinical trial to assess full spectrum medicinal  cannabis in children with ASD (Autism Spectrum Disorder).

Preparations for the trial are now almost complete, with 20 paediatric patients aged between 5-17 years to participate in 16-week study.

The trial will be a Phase I/II study to evaluate the safety and efficacy of orally administered NTI/DOLCE full spectrum medicinal cannabis plant extract.

This follows promising results from in vitro studies which demonstrated that the NTI/Dolce strains, with the newly discovered rarer cannabinoids CBDP and CBDB, have powerful, unique properties that extend beyond CBD.

For this study, Neurotech is working with Monash University paediatric neurologist Dr Michael Fahey,  which will pave the way for larger studies to address the unmet need for effective treatments in broader neurological conditions.

While other companies in the Australian cannabis sector are looking at over-the-counter sales opportunities, Neurotech is firmly focused on the vast potential of bringing an approved drug to market.

The company has also commenced discussions with Therapeutic Goods Administration (TGA), for the registration  of full spectrum <0.3% THC medicinal cannabis strains.

Strategic partnerships

The start of the clinical trial follows the announcement in March of a strategic cultivation partnership with CannaPacific.

The agreement aims to grow and maintain genetic stock, and assist in the development of elite varietal strains developed by NTI and Dolce Cann through their exclusive licensing agreement.

The partnership will also enable Neurotech to prepare expanded clinical studies in larger patient groups over the next six months.

In these upcoming trials, which are slated for Q2/Q3, CannaPacific will house the genetic stock and assist in the development of NTI’s exclusively licensed Dolce varietal strains.

Neurotech had earlier expanded its exclusive licence with Dolce Cann Global. It now covers not only autism, epilepsy and ADHD, but also includes all neurological disorders.

This includes diseases such as Alzheimer’s, Huntington’s, multiple sclerosis,  or any other disease or affliction affecting the human brain function.

The amendment of this licence provided scope for Neurotech to expand its research programs, as the NTI/Dolce full spectrum medicinal cannabis strains have been proven to reign superior over CBD alone.

The new licence deal followed an oversubscribed capital raising of $3.56 million, which includes $1.56 million from the exercise of options and the underwritten shortfall at 6c.

The fresh funds will be used to develop and market Neurotech’s Mente device, along with costs associated with the clinical study.

The Mente Autism device is the company’s first product, and is a portable electroencephalographic (EEG) medical device for home use in the form of a headband that helps relax the minds of children with ASD.

Earlier this month, Neurotech also appointed Krista Bates, an executive with a 20-year experience in commercial product rollouts.

The appointment comes as the global market for neurology treatments is expected to grow to $39.4 billion by 2024.

Neurotech’s share price has risen by 20 per cent in the last three months.

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.

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