The new licence won by Halucenex will unlock several opportunities for Creso Pharma in the global psychedelic market, and opens a pathway to a Phase II trial.

In yet another major development, global medicinal cannabis company, Creso Pharma (ASX:CPH),  announced that its wholly-owned subsidiary Halucanex has secured a monumental licence from Health Canada.

The Controlled Drugs and Substances Dealer’s Licence issued by the Canadian regulator will enable Halucenex to now progress its planned Phase II clinical trial, testing the efficacy of psilocybin on treatment-resistant post-traumatic stress disorder (PTSD).

The licence will also allow Halucenex to possess, sell, and conduct R&D activities on a range of approved controlled substances.

Securing the licence has made Halucenex one of only a few companies globally with the Dealer’s Licence, allowing it to work with psilocybin and other psychedelics under Health Canada’s directive.

Importantly, the licence will fast track the company’s Phase II clinical trial, which could unlock a number of future revenue-generating opportunities as the global psychedelic drug market is predicted to grow to US$6.8 billion by 2027.

Halucenex founder and CEO, Bill Fleming, said the receipt of the licence is the result of a stringent due diligence process undertaken by the regulator.

“To date, we’ve been focused on the lead-up to this milestone and have done a lot of essential preparatory work in anticipation of receipt of the Dealer’s Licence,” Fleming said.

“This will provide us with a significant competitive advantage as we progress our entry into the lucrative psychedelics drug space.”

Today’s licence approval follows the extension approval secured by Creso Pharma’s other subsidiary, Mernova, to sell medicinal cannabis in Canada announced just last week.

The dual licence means there are now additional  product development and integration opportunities that could potentially be leveraged between Mernova, Halucenex and Creso’s other partners.


Unlocking lucrative opportunities

The secured licence could unlock several opportunities within the PTSD therapeutics market, which is expected to reach a US$10.5 billion valuation by 2025.

It will also  provide Halucenex direct access to a large target market population of veterans, located near some of Canada’s largest army and naval bases in Nova Scotia.

However, the licence is subject to several restrictions and protocols.

For example, in the case of  substances covered by the Canadian Food and Drug Regulations, sales are restricted to research and clinical institutions, medical practitioners, and the Minister’s office.

Substances that fall under this directive include salvia divinorum and salvinorin A, GHB, harmaline, LSD, DMT and MDMA.

In the case of narcotics that are covered by the Canadian Narcotic Control Regulations, sales are restricted to other licensed dealers, pharmacists, medical practitioners, and hospital employees.

The licence, however, allows Halucenex to sell or provide psilocybin to other licensed dealers for the purposes of clinical testing or laboratory research, upon pre-approval by Health Canada.

Recent studies from John Hopkins University and other leading researchers have shown the benefits of psychedelic substances in treating a range of mental health issues.

Halucenex says it will leverage the licence to further integrate itself as one of the world’s leading companies in the emerging psychedelic assisted therapies sector.

The Dealer’s Licence itself is valid until 31 August 2022, and is subject to Health Canada’s standard licence renewal process thereafter.

“We are now very well placed to deliver on a number of value accretive initiatives, which have the potential to unlock significant value for shareholders and further cement our standing as a leader in emerging psychedelic inspired therapies,“ Fleming said.


Path towards a planned Phase II clinical trial

Following the receipt of the licence, Halucenex will now expedite its clinical trial application (CTA) with Health Canada over the next few weeks, which represents a key step in the commencement of its Phase II clinical trial.

The trial itself aims to test the efficacy of psilocybin on treatment-resistant PTSD.

Considerable progress towards the trial has already been made, which includes securing a number of key partnerships for patient recruitment, post trial care, and initial testing of its psilocybin product.

Chairman of The HighBrid Lab — a merged company between Creso Pharma and Red Light Holland — Bruce Linton, said he’s keen to explore opportunities provided by psychedelics as an evolutionary treatment route to existing therapies.

“As the mental health crisis continues to unfold, the need for effective treatments is becoming much clearer,” Linton said.

“The potential and requirements for new treatment pathways is also becoming widely recognised by regulatory bodies, governments and large pharmaceutical companies – all of which provide us with a number of avenues as we embark on test work, R&D and commercialisation.”

This article was developed in collaboration with Creso Pharma, 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.