The clinical trial, carried out by a wholly-owned subsidiary of Creso Pharma Limited, Halucenex Life Sciences Inc., will test the efficacy of psilocybin on treatment-resistant Post Traumatic Stress Disorder (PTSD).
Canadian-based psychedelics company, Halucenex Life Sciences, has now recruited 20 patients for the single-arm, open-lab trial. The patients include a number of veterans, Royal Canadian Mounted Police, firefighters, Emergency Medical Responders, psychologists, security officers and attorneys, amongst other occupations.
The goal of the trial is to determine the feasibility of future trials of psilocybin in this indication, and will be undertaken in line with Halucenex’s Clinical Trial Authorisation, awarded by Health Canada earlier in 2022.
Halucenex CEO and founder, Bill Fleming, commented: “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.”
The company has stated that, 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 amongst others.
This unique patient cohort provides Halucenex with the potential to test its synthetic psilocybin product on a broad range of individuals suffering from a number of debilitating conditions.
Fleming continued: “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.”
The trial will begin on 12 October 2022, following the administration of first dosages to patients, with completion expected by 14 December 2022.
Halucenex will utilise its 100%-owned and formulated synthetic psilocybin aqueous solution Lucenex, in both 10mg and 25mg formats.
The company has confirmed that, upon completion and subject to success in the trial, it will review all associated data to assess potential product development opportunities, licensing agreements, regulatory registrations and ongoing R&D into the use of synthetic psilocybin on PTSD and other conditions.
