Creso Pharma Ltd (ASX:CPH, OTCQB:COPHF) wholly-owned Canadian-based psychedelics subsidiary Halucenex Life Sciences Inc. has kicked off Phase 2 of its psilocybin clinical trial after securing the approval of the Research Ethics Board (REB).
The clinical trial will assess the efficacy of psilocybin when used to treat symptoms associated with treatment-resistant post-traumatic stress disorder (PTSD).
Halucenex has commenced patient recruitment through online portals and begun reviewing and shortlisting applicants. The patient recruitment protocols will be concluded shortly.
Significant patient enquiries
Halucenex chief executive officer and founder Bill Fleming said: “Being granted Ethics Board approval for the trial is a very important step in our R&D initiatives.
"Firstly, it highlights that the carefully designed process and protocols are in line with stringent regulations and will protect the dignity, rights, safety and welfare of all trial participants. Secondly, it will allow the company to commence the planned clinical trial into a condition as harmful as PTSD.
“Halucenex’s management and clinical trial staff have mobilised quickly following the REB approval and begun the patient recruitment process.
"We have received a significant amount of inbound enquiries, which further highlights the importance of our planned trial. We look forward to providing updates to shareholders, as required.”
Lucrative market
The REB approval follows a recent amendment to its Clinical Trial Authorisation (CTA) from Health Canada that allows Halucenex to capture a broader data set through a wider group of participants and on how psilocybin interacts when used in combination with other medications utilised by PTSD sufferers.
The first round of dosages will include Lucanex-branded treatments of 10mg and 25mg psilocybin finished product formulation.
Creso is banking on a successful trial to give it access to the lucrative PTSD therapeutics sector, which is expected to grow to US$10.5 billion in value by 2025.