Creso Pharma Ltd (ASX:CPH, OTCQB:COPHF)’s wholly-owned, Canadian-based psychedelics company Halucenex Life Sciences Inc. has secured Clinical Trial Authorisation (CTA) with Health Canada.
The CTA positions Halucenex as one of the few companies in Canada with clearance to begin a clinical trial utilising psychedelic substances.
Halucenex will now be able to progress the final steps towards the start of its planned phase II clinical trial to test the efficacy of psilocybin on treatment resistant Post Traumatic Stress Disorder (PTSD).
This is a major milestone for the Canadian company, which outlined its proposed trials objectives, design protocols and supporting data to Health Canada in January this year.
The January submission was subject to a 30-day review process by the regulator, prior to approval being granted.
Recruitment objectives to start immediately
Halucenex will begin its patient recruitment objectives and leverage its established relationships with veterans affairs groups across Canada.
The company will look to expedite the process, while continuing additional work with Acadia University towards clinical trial design and ethics approval.
Halucenex anticipates that the planned clinical trial will begin in Q2 CY2022.
Trials will involve 18 to 20 individuals (over 19 years old) that suffer from treatment resistant PTSD.
Creso Pharma believes the trial has the potential to unlock major market opportunity within the PTSD therapeutics sector, which is expected to grow to US$10.5 billion in value by 2025.
Culmination of over a year of hard work
Success in the clinical trial would allow Halucenex to progress several near-term opportunities including potential joint venture, licensing, product development and ongoing R&D initiatives.
“Securing Clinical Trial Authorisation solidifies over 16 months of hard work and dedication from our team and positions Halucenex as one of very few Canadian companies with approval to commence a clinical trial utilising psychedelic substances on mental health conditions,” Halucenex president, CEO and founder Bill Fleming said.
“We will immediately commence the formal patient recruitment process. 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.
“We look forward to providing additional updates to shareholders as we continue our rapid progress.”