Creso Pharma Ltd (ASX:CPH, OTCQB:COPHF) has made further progress in the potential treatment of Post Traumatic Stress Disorder (PTSD), after wholly-owned, Canadian-based psychedelics company, Halucenex Life Sciences Inc. recruited 20 patients for its phase II clinical trial, which will test the efficacy of psilocybin on treatment-resistant PTSD.
The clinical trial is designed to be a single-arm, open-lab trial that will ultimately determine the feasibility of future trials of psilocybin in this indication.
Having been awarded Clinical Trial Authorisation by Health Canada earlier in the year, Halucenex is free to start the trial under agreed guidelines.
Interest in trial continues to grow
Patient recruitment has followed several inquiries into the trial from local and international individuals suffering from PTSD.
An extensive review of backgrounds from each candidate’s application was conducted and patients include veterans, Royal Canadian Mounted Police, firefighters, Emergency Medical Responders, psychologists, security officers and attorneys.
While each participant has symptoms associated with PTSD, each also suffers from other mental illnesses including anxiety, suicidal thoughts, ADHD, OCD, depression, anger and anxiety.
This unique patient cohort provides Halucenex with the potential to test its synthetic psilocybin product on a broad range of individuals, suffering from debilitating conditions.
The trial will start on October 12, 2022, following the administration of first dosages to patients and is expected to be finished by December 14, 2022.
As part of the initiative, Halucenex will utilise its 100%-owned and formulated synthetic psilocybin aqueous solution Lucenex, in both 10mg and 25mg formats.
The company expects the trial to complete by December 14, 2022.
Potential product development
Once the trial is finished, Halucenex will assess the data to determine potential product development opportunities, licensing agreements, regulatory registrations and ongoing R&D into the use of synthetic psilocybin on PTSD and other conditions.
Halucenex CEO and founder Bill Fleming said of the trial: “The company has been receiving a steady stream of inquiries since news of the trial was announced and we are very pleased to have completed the patient recruitment process in such an efficient manner.
“Halucenex will now begin preparing its relevant treatment facilities for first dosages, which will be administered within the next two weeks. Clinical trial participants will be closely monitored closely and in line with all Health Canada regulations.
“We look forward to providing additional updates as the trial commences, initial dosages are administered and ultimately, interim results that will highlight how synthetic psilocybin can be used to treat such a debilitating condition.”