In a major step towards a Phase II clinical trial Halucenex has received favourable results from stability testing for its GMP grade psilocybin.

Global medicinal cannabis company Creso Pharma (ASX:CPH) has announced its wholly-owned psychedelics subsidiary Halucenex Life Sciences’ psilocybin active pharmaceutical ingredient (API) has now been deemed safe for human consumption following positive lab results.

Halucenex completed all USP 61 and USP 62 stability testing requirements ahead of a phase II clinical trial with the favourable test results highlighting superior concentration of between 98.6% and 99.8% in GMP grade psilocybin with minor impurity levels.

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

Completion of the USP 61 and USP 62 testing and favourable results mark a major milestone in the company’s planned Phase II clinical trial to test the efficacy of API on treatment resistant Post Traumatic Stress Disorder (PTSD).

 

Halucenex plans to start API Phase II trial in 2022

Testing was undertaken alongside leading R&D partner Nucro-Technics with the positive results enabling Halucenex to progress the final steps in lodging its Clinical Trial Authorisation (CTA) with Health Canada.

Halucenex expects to file its CTA before the end of November 2021, which will be subject to a 30-day review by the regulating body. Receipt of the CTA will allow Halucenex to progress its planned Phase II clinical trial by Q2 CY2022.

The company’s clinical trial will test the efficacy of psilocybin API on treatment resistant PTSD. The trial is also forecast to provide Halucenex access to several opportunities in the PTSD therapeutics sector, which is estimated to be valued at US$10.5 billion by 2025.

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 with ~20 adults that suffer from treatment resistant PTSD to be enrolled.  The company said it has ample supply of API to commence the trial.

 

Halucenex focused on bringing quality product to market

In July, Creso completed its acquisition of Halucenex, a clinical stage company focused on using psilocybin to treat PSTD, TRD and anxiety. Halucenex is one of only three Canadian companies licensed to handle 10kg of psilocybin at any one time.

Haluecenex founder and CEO Bill Fleming said the results highlight the significantly high grade and concentration of their GMP grade psilocybin samples, which is a key competitive advantage.

“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,” he said.

Fleming said with treatment resistant PTSD being widespread, the company expected patient recruitment to be seamless and finalised during Q1 CY2022, ahead of trial commencement shortly thereafter.

“Additional work is underway across product development and clinical trial design, and we look forward to updating shareholders regularly over the coming months,”  he said.

Non-executive chairman Adam Blumenthal said the completion of the stability test work highlights a significant advancement in the company’s efforts to commence the planned Phase II clinical trial.

“The results highlight that the company’s product is stable and safe for human consumption and will make up a large part of our CTA,” he said.

“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.

“This is a major opportunity for Creso Pharma to become a market leader in the psychedelics sector.”

While Creso is known for developing cannabis and hemp-derived therapeutic, nutraceutical and lifestyle products for both people and animals, co-founder Dr Miri Halperin Wernli has a strong interest in psychedelic drug development. She is also president of the $US1.2 billion Mind Medicine Inc.

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.

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