If successful, Halucenex’s Phase 2 clinical trial is expected to give Creso Pharma access to a multibillion dollar sector.

In a major development today, Creso Pharma (ASX:CPH)’s wholly-owned psychedelics subsidiary Halucenex Life has been given the green light by Canadian authorities to commence a Phase 2 clinical trial.

The Clinical Trial Authorisation given by Health Canada will allow Halucenex to make the final steps towards the Phase 2  trial to study the efficacy of psilocybin as a treatment for resistant Post Traumatic Stress Disorder (PTSD).

The approval follows an initial submission from Halucenex to Health Canada in January,  which detailed the proposed trials objectives, design protocols and supporting data.

It’s anticipated that the trial will start during Q2 of this year.

“Securing a Clinical Trial Authorisation solidifies over 16 months of hard work and dedication from our team,” said Halucenex president, CEO and founder, Bill Fleming.

“This now positions Halucenex as one of very few Canadian companies with approval to commence a clinical trial utilising psychedelic substances on mental health conditions,” he added.


Preparing for the trial

Creso acquired Halucenex in July last year, giving it immediate  access to the emerging global market for psychedelic medicines estimated to be worth up to US$100 billion.

Halucenex is focused on developing novel psychedelic molecules to treat post-traumatic stress disorder (PTSD), depression and other mental illnesses.

It operates a 557 square metre medical clinic in Windsor, Nova Scotia, and aims to become a clinical drug pipeline provider of psilocybin products.

Prior to today’s approval, Halucenex had already made great strides in preparation for the trial.

The company had completed all USP 61 and USP 62 stability testing requirements, proving that its ingredients are safe for human consumption.

The test results highlighted superior concentration in its ingredients of between 98.6% and 99.8% in GMP grade psilocybin with minor impurity levels.


Multibillion dollar opportunity

Halucenex will now progress patient recruitment for the trial, with the plan to enrol 18 to 20 individuals (over 19 years old) that suffer from treatment resistant PTSD.

The company says it will leverage its established relationships with veterans affairs groups across Canada to expedite this process, while continuing additional work with Acadia University towards clinical trial design and ethics approval.

“Given our longstanding relationships with a number of veterans affairs groups and the prevalence of treatment resistant PTSD across North America, we anticipate that this will be a seamless process,” said Fleming.

The Phase II trial is designed to be a single-arm, open-lab trial that will ultimately determine the feasibility of future trials of psilocybin for PTSD.

Success in the trial would also allow Halucenex to progress a number of potential opportunities in the PTSD therapeutics sector, a market that’s expected to reach  US$10.5 billion by 2025.

Subsequent to the completion of the clinical trial and subject to success in the trial, Halucenex says it will pursue potential joint venture, licensing, product development as well as ongoing R&D initiatives.

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.