Creso Pharma Ltd (ASX:CPH, OTCQB:COPHF) welcomes the news that wholly-owned, Canadian-based psychedelics company Halucenex Life Sciences Inc has successfully administered first doses of its Lucenex branded 10mg and 25mg synthetic psilocybin formulation.
A patient was dosed, in separate sessions, as part of the company’s Phase 2 clinical trial, marking the commencement of the initiative. The dosage has not shown any observed adverse effects.
PTSD therapy
Halucenex’s clinical trial is a single-arm, open-lab trial that will test the efficacy of psilocybin on treatment-resistant Post Traumatic Stress Disorder (PTSD) and ultimately determine the feasibility of future trials of psilocybin in this indication.
A group of 20 participants has been recruited to the trial and each will receive one 10mg microdose and then a 25mg macrodose.
All the recruits suffer from PTSD and other mental health disorders including anxiety, depression, ADHD and OCD.
The trial is expected to wrap up during the second quarter of 2023.
Halucenex will pursue additional clinical trial protocol amendment with Health Canada to investigate sleep disruption, which is one of the most impactful PTSD symptoms.
Trial score amendment
The company is seeking a clinical trial amendment with Health Canada that will alter the clinical trial score requirement for the severe PTSD indication.
This process is underway and Creso will continue to progress the trial in the interim.
Following the administration of its 100%-owned and formulated synthetic psilocybin aqueous solution, Lucenex, to the first patient, Halucenex will continue administering its synthetic psilocybin to an average of two patients per week, allowing for completion in the second quarter of the new year.
Tapping into global sleep market
The global sleep aid market size is a large addressable market, predicted to be worth US$97.3 billion by 2027.
A successful trial outcome has the potential to unlock a major market opportunity for Creso Pharma and unlock access to the PTSD therapeutics sector which is expected to grow to US$10.5 billion in value by 2025.
What’s next?
Upon completion and subject to the success of the trial, Halucenex will undertake an extensive review of data generated and the effect of synthetic psilocybin when used to treat symptoms associated with PTSD.
The company will also simultaneously conduct a review of additional product development opportunities, R&D initiatives and potential licensing agreements.
Halucenex CEO and founder Bill Fleming said: “Administering first dosages of our 100%-owned and formulated synthetic psilocybin follows a considerable amount of work undertaken by Halucenex in the recent months and highlights the potential opportunity that the company has at hand.
"Having witnessed no adverse effects from the initial dose also provides us with confidence in moving to the next phase.
“Having now completed the first patient dose, we look forward to continuing to work with our clinicians over the coming weeks to complete the administration of psilocybin and monitor patients for improvement in symptoms. The company expects to be in a position to provide additional updates on developments over the course of the trial.”