Apex Labs Pioneers Take-Home Psychedelic Treatment

There has been no shortage of first-of-their-kind psychedelic clinical trials over the past few years. There have historically been very few studies testing psychedelics for clinical use, so each one brings the promise of new and effective treatments hitting the market. 

Most recently, Apex Labs received approval for the largest take-home clinical trial testing psilocybin for the treatment of depression and anxiety within PTSD. A few unique characteristics of this phase 2b trial will offer data for practices that have never been studied on a large scale. In addition to being a take-home trial, Apex will test microdosing instead of the more commonly studied macrodosing. Microdosing offers unique solutions to PTSD and other indications. 

A microdose is a small dose of a psychedelic, and with psilocybin, it is not associated with a hallucinogenic effect. Microdosing has become popular among the psychedelic community, however, it is largely untested in a clinical setting. That is the problem with many practices regarding psychedelics. They have been used underground for decades, and those who use them have developed best-practice protocols. Those practices must be tested in a clinical setting before being accepted in the medical community– which is crucial in expanding patient access. 

There have already been several studies proving that psilocybin is a safe and effective treatment for PTSD, depression, and addiction. However, there is minimal data on the effects of microdosing for these indications. Microdosing may be more suitable for patients with mild to moderate disease. Apex Labs is pioneering the future of microdosing psilocybin alongside the state of Oregon! 

The regulations for The Oregon Psilocybin Services Act include rules allowing microdosing. The state will allow an increase in the facilitator-to-patient ratio if the dose of psilocybin is below a certain point. When receiving a microdose, people will only be required to stay in the facility for an hour, compared to a much longer time requirement for macrodoses. This may lead to the rise of microdosing coffee shops, yoga studios, and wellness centers. It offers those seeking the benefits of psilocybin a much more affordable option than macrodosing. 

What Oregon is doing to help people gain access to the benefits of microdosing is excellent for people in Oregon, however, many still lack access to treatment. It needs to go through the proper approval process as a pharmaceutical drug to change that– Apex Labs is leading the way in making that happen. 

Apex Labs is a pharmaceutical company based out of Canada. Psychedelic Invest got to sit down with Apex Lab’s CEO, Tyler Powell, and one thing was apparent– giving people access to affordable and safe psilocybin treatment drives every decision they make. 

Powell was beyond excited that they could offer 294 patients access to pharmaceutical-grade psilocybin microdose treatment through the recently approved phase 2b clinical trial. The company’s target market is primarily Veterans in Canada and the US struggling with PTSD, but the trial allows any eligible patient with PTSD to be considered for participation. Many Veterans are already utilizing psilocybin through the underground market, but the quality and dosage are difficult to gauge without regulations in place. 

This trial will be the most extensive study looking at the benefits of microdosing psilocybin in a take-home study. The data from the trial will set future standards of practice with microdosing. The approval from Health Canada came at the end of January– shortly after the dosing of their first patient in a smaller risk mitigation clinical trial. The risk mitigation study is focused on demonstrating that patients currently using take-home “unregulated” psilocybin microdoses could be safely switched to our APEX-52 microdose synthetic psilocybin demonstrating efficacy. 

The companies in the psychedelic space are setting the groundwork for the future of psychedelic treatment. They are setting the groundwork because they are the first to study psychedelics in a clinical setting, and Apex is doing that for take-home microdosing. 

In addition to offering patients with mild to moderate symptoms a new kind of treatment, Apex Labs’ protocols would increase accessibility. Psychedelic treatment is costly. It requires several medical professionals to be on hand for 6+ hours during treatment and includes preparation and integration sessions at additional cost. Having a take-home option drastically decreases the cost and time required to receive treatment, making it easier for people to access. 

During the trial, the patients will take the first dose in the presence of a psychotherapist, but the following doses will be taken at home. The trial will include journaling and other integration practices to help the patients get the most out of their treatment. Apex was not able to give us specific details on dosage and frequency of dosage. We know that Health Canada defines a microdose as under 10mg of psilocybin. The psychedelic community, however, generally uses around 200mg as a microdose. Standard protocols for microdosing include 3-4 days a week and taking the rest of the week off from treatment. A round of microdosing generally lasts 6-8 weeks. 

Another thing that makes this type of drug different than the other psilocybin drugs currently going through the pipeline is that it requires continued dosing. Trials testing macrodosing usually include around 1-3 dosings. With a higher number of dosings, more money will be spent on the drug but less on supporting services such as therapists, medical support, and clinic infrastructure, which are the most costly elements of administering psilocybin in a clinical setting. 

The company hopes to complete the trial by the end of 2023, with results available in 2024. The results will inform the phase 3 trial and other future trials aimed at supporting all patients navigating these diseases in Canada, the US, the EU, and Australia. 

Apex believes that microdosing could be beneficial when used in tandem with macrodoses to improve the overall treatment outcome and may explore this area in future studies in addition. 

Apex Lab’s unique approach to treatment, first-movers advantage, fervent commitment to the  Veteran community, and objective to support all patients with depression, anxiety, and PTSD in Canada, the US, the EU, and Australia makes them a company to watch over the next few years. The approval of this trial is a big step not just for the company but for the psychedelic industry as a whole.