Apex Labs is using a take-home psilocybin-based drug to treat PTSD and depression in veterans

While other provinces are still probably gawking at B.C.’s decriminalization of small amounts of illicit drugs, some local businesses are already elbow-deep in using yet-to-be-legalized substances to treat illnesses. Take Apex Labs, for instance.

The Vancouver-based pharmaceutical company has been working on developing and marketing clinically tested psilocybin-based drugs to improve mental health since 2020, with a focus on treating depression in veterans with PTSD. Its clinical trial, APEX-002-A01-02, is sharpening that focus by evaluating the safety and efficacy of low-dose psilocybin (a compound in magic mushrooms) to meet the therapeutic needs of veterans.  

“There is a very large population of veterans taking an illicit or unregulated microdose currently,” says Apex CEO Tyler Powell. “The problem with that is you have no idea where that’s made, you have no idea what the purity is—there’s nothing to regulate that drug. And that is exactly the doubt that we’re looking to remove with our drug, which is a GMP-manufactured, pharmaceutical-grade product that could replace what patients are already taking on their own.” 

Health Canada just approved phase two of the APEX-002-A01-02 trial, marking the first official take-home psilocybin clinical trial in the country. The take-home aspect is particularly important in light of the relatively low number of therapists and clinicians trained in psilocybin therapy.  

This milestone has been years in the making, coming to a head at the start of this year when Health Canada added psilocybin and MDMA to its Special Access Programme (SAP, which grants practitioners access to unapproved drugs in certain cases). Apex supported the process for the first in-clinic psilocybin-assisted psychotherapy to get SAP approval for six palliative patients.

In addition to early access programs like the SAP, the company’s clinical pipeline includes this take-home drug trial. Apex will be dosing its first patient with in about 30 days and the trial is expected to last around two months.  

Three years ago, when Powell noticed people mimicking cannabis business models for psychedelics, he quickly identified one of the missing components: the Big Pharma play. The Vancouverite, who studied psychology at St. Mary’s University in Halifax and spent 15 years in finance and capital markets, began working with the three other co-founders of Apex around then. The team has since worked with many physicians that have seen patients heal with psilocybin-assisted therapy. Powell himself has met veterans who can vouch for the efficacy of the drug in treating mental illnesses. This is perhaps due to its less-severe side effects compared to traditional antidepressants.  

“We’ve raised just shy of $5 million to get to where we are,” Powell adds. “We have well over 200 B.C. shareholders that believe in the company, an independent board of directors and all the keys to take this company to the next level… this is all part of the push for medical access for patients. Whichever way that comes about, we’ll support it, whether it’s for take-home or therapists or both. We’re here to support that movement.”