Creso Pharma Ltd (ASX:CPH, OTCQB:COPHF)’s wholly-owned subsidiary Halucenex Life Sciences Inc has reached the penultimate step before its psilocybin clinical trial can proceed after securing an amendment from Health Canada for its Clinical Trail Authorisation (CTA).
Halucenex’s Phase 2 clinical trial will assess the efficacy of psilocybin when used to treat symptoms associated with treatment-resistant post traumatic stress disorder (PTSD).
The recent amendment granted by Health Canada will allow patient cohorts already using other medication associated with PTSD management to participate in the trial, if selected by Halucenex.
This change will allow the company to collect data around psilocybin’s use alongside other pharmacological treatments that may be used in concert to treat the symptoms of PTSD.
Halucenex has made the final Ethics Review Board submissions, and expects to receive the outcome of the board’s deliberation imminently.
“Major step forward”
“To have secured this amendment from Health Canada is a major step forward for Creso Pharma, Halucenex and patients managing symptoms associated with PTSD while using other medication,” Creso Pharma managing director and CEO William Lay said.
“This clinical trial has the potential to unlock a new and natural alternative to current pharmacological treatments used by PTSD sufferers, while unlocking a new market for the company.
“We continue to liaise with our Ethics Review Board, potential patient groups and all clinical trial personnel and expect to administer first dosages to patients in or around September 2022 (subject to ethics review approval).
“I look forward to providing additional details on developments in due course.”
The first round of dosages will include Lucanex-branded treatments of 10mg and 25mg psilocybin finished product formulation.
The company believes this trial has the potential to unlock a large market opportunity for Creso, gaining access to the PTSD therapeutics sector, which is expected to grow to US$10.5 billion in value by 2025.