Fresh from revealing its proposed acquisition of Canadian psychedelics company Halucenex, Creso Pharma (ASX: CPH) has announced the appointment of a lead investigator for its target’s phase two clinical trial.
Creso earlier this week announced its intention to acquire Halucenex Life Sciences Inc, a decision the company says will transform it into a diversified natural pharmaceuticals business and give it an early mover advantage into the psychedelic medicines sector.
Focused on developing novel psychedelic medicines, Halucenex is aiming to commence a phase two clinical trial testing the efficacy of psilocybin (the active ingredient in magic mushrooms) on treatment-resistant post-traumatic stress disorder (PTSD) in veterans and first responders.
In an update today, Creso advised that Halucenex has appointed True North Clinical Research as the principal investigator for the study, which is expected to begin in June subject to authorisation being granted by Health Canada.
According to Creso, True North is a leading research and development group with “strong ties to the Canadian armed forces and veterans, which will be imperative to the trial”. In particular, the group’s founder and chief executive officer Dr Mark Johnston has worked with various military organisations over his 20-year career as a psychiatrist.
Dr Johnston said Halucenex is excited to undertake this potentially ground-breaking research because “despite more than a million veterans around the world being diagnosed with PTSD, effective pharmacological treatments are sorely lacking”.
Halucenex founder and chief executive officer Bill Fleming added that the study will allow the companies to bring their clinical trial and psychological expertise together “to maximise the benefit for current and future patients”.
“We look forward to a long, productive and successful relationship with True North,” he said.
“Veterans and first responders give so much to society on a daily basis and we owe it to them to find the most effective treatments possible. This trial is a major step in the right direction,” Mr Fleming added.
As lead investigators, True North will provide clinical oversight into the trial, assist with facilitation of compliancy with the Nova Scotia Ethics Committee, undertake patient recruitment initiatives, conduct the trial, monitoring, data capture and compilation of results and ensure follow-up measures are taken to ensure participant safety.
Phase two clinical trial
The proposed study is a phase two, single arm, open label trial to determine the efficacy and safety of psilocybin in individuals with treatment-resistant PTSD. The research will also ultimately determine the feasibility of future trials of psilocybin in this indication.
Halucenex expects to recruit about 18 to 20 adults with the condition and treat them with two separate doses of psilocybin seven days apart: a 10mg micro dose is to be administered on day seven followed by a 25mg macro dose on day 14.
Patients will be closely monitored in the clinic during the hallucinogenic period with safety assessments conducted including incidents of adverse effects and vital signs.
At six to seven hours post-dosing, patients will subjectively rate the intensity of psilocybin’s effects. They will also be required to return to the clinic on the days after treatment for efficacy and safety assessments.
Patient identification criteria has already begun with the trial scheduled to start in June subject to the receipt of a clinical trial authorisation permit by Health Canada. The required documentation to obtain this permit is expected to be lodged by the end of April.
Halucenex boss to replace Creso director upon acquisition
Creso also advised that Mr Fleming will replace Dr Miri Halperin Wernli as a director of Creso upon completion of the acquisition.
Creso non-executive chairman Adam Blumenthal thanked Dr Halperin Wernli for her commitment to Creso in today’s announcement.
“During her time in office, she has been pivotal in Creso Pharma’s success and delivered an immense amount of value to the board and management team, as well as led a number of initiatives, which have unlocked considerable value for our shareholders,” he said.