First Take-Home Psychedelics Clinical Trial In North America Will Target PTSD

Vancouver-based psychedelics biopharma company Apex Labs Ltd. has received Health Canada’s approval to conduct the first North American take-home clinical trial evaluating the safety and efficacy of multiple low doses of self-administered oral synthetic psilocybin compound APEX-52 for the treatment of depression in veterans with PTSD.

Apex Labs is set to optimize the standard of mental health care specifically for the veteran population by offering clinically-backed psilocybin medicines to market for depression in PTSD. Besides developing the products, the company intends to evaluate their safety and efficacy in a real-world setting by simultaneously working with veterans and their primary healthcare practitioners to develop effective channels for providing patients access to these treatments.

In view of the No Objection Letter (NOL) filed by the Canadian federal agency on October 24th in response to Apex’s application, the company’s CEO Tyler Powell said this approval “signals a willingness from Health Canada to allow Apex to move forward with a clinical pipeline focused on veteran patients with PTSD and a comorbid diagnosis of depression.” 

Apex CEO further explained: “Veterans are already self-medicating with micro-doses of unregulated psilocybin products without knowing the potency and safety of the product they are consuming. Our goal is to expand access to pharmaceutical grade drug products through regulated systems, providing transparency and support for patients in need."

The two-month trial will include a psychiatric overview. Nonetheless, its importance relies on the fact that it is the first clinical study allowing participants to consume a Good Manufacturing Practice (GMP) psilocybin drug product at home alone, which could help reduce the stigma associated with taking the psychedelic.

Arron Victory, the company’s chief strategy officer, believes Apex’s specific focus on the veteran community led to Health Canada’s approval. “It’s a nuanced approach to treating veterans with PTSD, and the current standard of care -talk therapy combined with antidepressants- has been an acknowledged failure in the veteran community,” he said.

According to Victory, the currently approved treatment doesn’t work for veterans with PTSD due to moral injury. “That’s when something you’ve witnessed is so traumatizing it basically erodes your current belief system,” Victory explained. “PTSD is an epidemic in the veteran community, and when you have a chronic condition that’s treatment-resistant, you’ll try anything once.”

Besides, he added, growing interest in using psilocybin as a treatment for depression owes to the fact that -unlike other medications- it does not seem to hold addictive properties.

Canada appears to be slowly moving towards regulated approval for the advancement of psychedelics as medicine. Recently, an Ontario university received a Health Canada Dealer’s License enabling the cultivation of psilocybin mushrooms for further research.

Photo by Rowan Heuvel on Unsplash