Vancouver-based Apex Labs has received approval for a Phase IIa clinical trial exploring psilocybin treatment for post-traumatic stress disorder (PTSD) in veterans.
Health Canada has provided its No Objection Letter to the company for the trial application. The trial is a randomised, double-blind, placebo-controlled dose-finding study that will evaluate the safety, tolerability and efficacy of psilocybin in veterans with PTSD.
In Canada, with 9 per cent of the population suffering from PTSD at least once in their lives – the condition is the ninth leading cause of deaths nationwide which are attributed to suicide – averaging at 11 per day. An estimated, 9 per cent of PTSD patients are not receptive to current treatments, and to add to this burden, around 50 per cent of people with PTSD will suffer from depression.
Apex CEO and director, Tyler Powell, commented: “The team at Apex Labs has worked tirelessly to achieve this milestone and believe our company has quietly positioned itself to be a leader in the North American psychedelics space through a strategy utilising our clinical expertise, connection to veteran patients and our commitment to broader access to regulated psychedelic drug products for therapeutic benefit.”
The company has so far established its patient base of veterans, along with the trial location and a qualified Investigator. The Phase IIa programme is expected to launch towards the middle of 2022.
For the trial, Apex’s psilocybin drug product APEX-002-A01 will be used. The company highlights that it has sourced GMP and non-GMP psilocybin from Psygen to advance its research and development, working with Psygen on arranging all supporting chemistry, manufacturing, and controls data, quality overall summary and investigator brochure for the clinical trial application.
Apex, which is aligned with TheraPsil, a non-profit advocacy group focused on psilocybin medical access, has stated that its clinical development programme is focused on veterans as this is a population disproportionately affected by mental health conditions.
The company has stated: “Currently Health Canada allows psilocybin access to patients through two avenues outside of clinical trials, subsection 56(1) exemptions and the recently revised Special Access Program (SAP).
“With Therapsil’s assistance, APEX has filed subsection 56(1) exemptions for Veterans to access psilocybin for therapeutic benefit where other treatments have failed. APEX believes that the SAP will provide an additional path to medical access in specific cases.”
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