The independent report by the TGA could potentially down-schedule the use of psychedelic substances, opening the door for Creso Pharma to capture the Australian market as a first mover.

Global medicinal cannabis company, Creso Pharma (ASX:CPH), announced that its wholly-owned subsidiary Halucenex has commenced stability testing initiatives for its GMP grade psilocybin, ahead of the Phase II clinical trial.

The initiative aims to provide additional validation of its GMP grade psilocybin, with testing now underway alongside its R&D partner, Nucro-Technics.

Stability testing is a critical step in drug development, and is utilised to determine whether the quality of a drug substance is altered over time by various environmental factors including light, temperature and humidity.

In another major development, the Australian Therapeutic Goods Administration (TGA) has released an independent report on psilocybin and MDMA, which highlights the potential use of psychedelic substances to treat treatment-resistant mental illnesses.

This marks a major development in the potential for the TGA to down-schedule psilocybin and MDMA from schedule 9 (prohibited drug), to schedule 8 (controlled drug).

“The recently published report from the TGA highlights the ongoing shift and acceptance towards the use of psychedelic substances as alternative treatment routes, and coincides with a pivotal step in the company’s USP 61 and USP 62 testing initiatives,” commented Creso’s non-executive chairman, Adam Blumenthal.

Blumenthal also said he’s confident the data generated through the company’s planned Phase II clinical trial will also echo TGA’s claim.


Halucenex’s stability testing

Halucenex will test a range of samples over a seven and 14-day period to ensure its psilocybin is fit for human consumption.

This data will also allow the company to progress its Clinical Trial Authorisation with Health Canada, enabling the commencement of its planned Phase II clinical trial.

Halucenex had earlier secured a Controlled Drugs and Substances Dealer’s Licence from Health Canada back in August.

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

The licence has also fast-tracked the company’s Phase II clinical trial, which is expected to 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.

The Phase 2 trial will study the efficacy of psilocybin when used for the treatment of treatment-resistant Post Traumatic Stress Disorder.

The company says that data captured from the current stability testing will be crucial for future drug and product development initiatives containing Halucenex’s GMP grade psilocybin.

“Stability testing is an important part of our USP 61 and USP 62 protocol work, as well as future drug development, and one of the final steps that needs to be undertaken to finalise our documentation for Clinical Trial Authorisation,” said Halucenex founder and CEO, Bill Fleming.

Fleming also said that given the excellent quality of its psilocybin, he anticipates the company will witness positive results from the rigorous testing protocols, which will assist in a number of future initiatives.

Halucenex  expects to update the market upon completion of the testing protocols results within the coming weeks.


TGA’s independent report on psilocybin and MDMA

The TGA has just released an independent expert panel report which highlights that psychedelic substances could potentially be used to treat treatment-resistant mental illnesses when used in closely supervised clinical settings, with intensive professional support.

Pending the regulator’s review into the risks and benefits to public health outcomes for these substances, both psilocybin and MDMA could now potentially be down-scheduled from a prohibited drug status to a controlled drug status.

This follows the decision to down-schedule medicinal cannabis from schedule 9 to schedule 8 back in 2016.

The TGA report released today was reviewed by an independent panel of experts on mental health, and highlights the ongoing shift towards evolutionary therapies.

A final decision is expected to occur in early December, and Creso Pharma is already exploring a number of Australian-based R&D and clinical trial initiatives, which it will pursue upon a favourable shift in legislation.

The company has already developed a large body of evidence for the use of psilocybin as an alternative treatment route, which it will leverage to capture a material share of the Australian market as a first-mover.

“The management team has been exploring potential opportunities in the Australian market for some time, and the TGA’s recent announcement validates the potential opportunity that Creso Pharma has at its disposal in Australia,” said Blumenthal.

“We look forward to TGA’s final decision, and leveraging this to progress a number of domestic opportunities which will unlock considerable value for shareholders.”

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.