Creso Pharma Ltd (ASX:CPH, OTCQB:COPHF)’s wholly-owned, Canadian-based psychedelics company, Halucenex Life Sciences Inc. has received results described as "exceptional" from laboratory testing initiatives, highlighting the quality of Halucenex’s psilocybin API.
Halucenex has now completed all USP 61 and USP 62 testing requirements, which is a major step toward phase II clinical trial, with API now deemed safe for human consumption ahead of the phase 2 trial, which will test the efficacy of psilocybin on treatment-resistant Post Traumatic Stress Disorder (PTSD).
“We are very pleased to have achieved such outstanding testing results,” Halucenex CEO and founder Bill Fleming said.
“These highlight the significantly high grade and concentration of our GMP grade psilocybin samples, which is another key competitive advantage for Halucenex and the Creso Pharma group of companies.
“We will now finalise our CTA and submit to Health Canada in the coming weeks. Clinical Trial Authorisation is the final piece in the commencement of our planned initiatives, which will unlock a number of substantial opportunities for the company.”
Breaking down the tests
The USP 61 test provides enumeration of mesophilic bacteria and fungi that may grow under aerobic conditions. This test provides the total number of aerobic organisms, yeast and mould present within a sample. The sample is typically diluted, plated and then incubated with results used to determine whether or not compounds can be used for human testing.
A USP 62 test evaluates a product for the presence or absence of potential pathogens. USP 62 tests are necessary for cosmetic and personal products to determine that any microorganisms that may be present in a product are not specific pathogenic microorganisms of particular concern if found in a consumer product.
Halucenex conducted their tests alongside leading R&D partner Nucro-Technics.
The tests highlighted that Halucenex’s psilocybin API samples showed a concentration range of between 98.6% and 99.8%, highlighting the minimal impurity and superior quality and showed the products to be safe for human consumption.
These tests have paved the way for Halucenex to progress the final steps in lodging its Clinical Trial Authorisation (CTA) with Health Canada, which it intends to do before the end of November 2021.
A 30-day review by the regulating body will follow and receipt of the CTA will allow Halucenex to progress its planned phase II clinical trial by Q2 CY2022.
The proposed phase II clinical trial is designed to be a single-arm, open-lab trial that will ultimately determine the feasibility of future trials of psilocybin in this indication. It is planned that 18 to 20 individuals (over 18 years old) that suffer from treatment-resistant PTSD will be enrolled in the trial.
“Following the 30-day review from Health Canada and potential CTA grant, we will be able to commence the ethics approval and patient recruitment process,” Fleming said.
“Sadly, treatment-resistant PTSD is widespread, so we anticipate that patient recruitment will be seamless and finalised during Q1 CY2022, ahead of trial commencement shortly thereafter.”
Entering a multi-billion sector
Halucenex’s clinical trial will test the use of psilocybin on treatment-resistant PTSD.
There are a number of opportunities in the PTSD therapeutics sector, which is estimated to be valued at US$10.5 billion by 2025.
“Halucenex has made very pleasing progress since becoming part of the Creso Pharma group and we look forward to working alongside Bill and his team as it begins to scale operations ahead of the clinical trial,” Creso’s non-executive chairman Adam Blumenthal said.
“This is a major opportunity for Creso Pharma to become a market leader in the psychedelics sector.”