Canada relies on magic mushrooms for major depression and PTSD

Psilocybin, the primary psychoactive compound in “magic mushrooms,” has been linked to recreational drug use and the 1960s counterculture. However, recent research over the last two decades has shown that it can potentially treat various mental and behavioral disorders.

Health Canada completed a comprehensive 160 patient psilocybin study, including macro and multiple doses, by Apex Labs Ltd. approved. This Canadian biopharmaceutical company is also advancing at-home psilocybin microdosing studies and supporting experienced patients. The study was classified as “statistically sound”.

SUMMIT-90

The Company’s Phase 2b trial, known as SUMMIT-90, is a double-blind, placebo-controlled, multi-site clinical trial. It evaluates the effects of repeated macrodoses of its synthetic psilocybin APEX-90 coupled with exclusive psychotherapy on participants diagnosed with major depression and PTSD.

To fill gaps in current macrodose studies, a precise dose was selected for administration in multiple doses over three months. The entire investigation, including screening, recruitment, treatment and post-treatment impact measurement, is expected to take a year.

Patient enrollment for the study is expected to begin sometime this quarter. The primary indication for the study is major depression associated with PTSD, while the secondary indications include chronic pain, anxiety, and PTSD symptoms in their own right. Symptom severity is measured using scales that assess changes from baseline.

Tyler Powell, co-founder and CEO of Apex, said the federal approval validates the urgent need for improved health alternatives. dr Peter Tomlinson, CMO, added that the dosing regimen for this study was optimized for sustained efficacy and focused on patients suffering from the most severe form of the disease.

Following a successful proof-of-concept clinical trial, Apex has optimized its proprietary psychedelic compound for the treatment of mild to moderate depression in its ongoing Phase 2b PATHFINDER-52 trial. The study includes microdoses of psilocybin to take away. Dosing for this study is expected to begin in mid-2023. Centricity Research will conduct both SUMMIT 90 and PATHFINDER 52 studies at five sites in Canada.

Apex’s commercial path

Greg Rutherford, Apex CCC, revealed to Benzinga the commercial path the company intends to pursue, which includes:

• Significantly improved clinical and patient outcomes compared to current standards of care in the treatment of standalone depression and anxiety and depression and anxiety associated with diagnosed PTSD. This enables the final approval of a broad and optimal treatment label.

• Streamline access to your treatment resources by securing regulatory approvals in the US, Canada, Australia and the EU, along with commercial listings and drug reimbursements.

Given his extensive background in the big pharmaceutical industry, Rutherford expects healthcare stakeholders to take notice of the company once registration for both clinical trials begins. If the endpoints are met and the outcome data is compelling, these stakeholders will analyze the study results and take further action as appropriate.

According to Rutherford, the pharmaceutical industry usually strives to acquire compounds after phase 2b studies. They then plan and conduct pivotal phase 3 clinical trials using their clinical and regulatory infrastructure and commercial know-how. That means they aim to acquire assets that offer significant commercial potential at a Phase 2 price point.

Benefits of Magic Mushrooms

The notion that psilocybin has no medicinal uses is not supported by scientific evidence is not true. Although more research is needed, strong evidence suggests that psilocybin has therapeutic benefits in the mental health field. Some therapeutic benefits of psilocybin include:

depression

During a study conducted in 2022, a group of researchers examined the effects of psilocybin on 27 people who had suffered from depression for a prolonged period. The study involved administering two doses of psilocybin to each participant every two weeks between August 2017 and April 2019.

The study found that subjects’ depression scores remained low at 1, 3, 6, and 12 months after treatment. While this is encouraging, the researchers stressed the need for more research to fully understand the link between psilocybin and depression. In particular, it must be determined whether the benefit of the treatment persists beyond 12 months.

Post-Traumatic Stress Disorder (PTSD)

A study in mice showed that low doses of psilocybin effectively conditioned the fear response. This could mean that magic mushrooms could potentially treat PTSD and related conditions. However, more human research is needed to confirm this link.

Additionally, research shows that the psychological effects of psilocybin can be uncertain, making it difficult to determine with absolute certainty the effectiveness of magic mushrooms as a treatment for PTSD.

Fear

More research is needed to determine psilocybin’s effectiveness in treating anxiety, but preliminary studies are showing promising results. In a 2016 study, 51 cancer patients with life-threatening diagnoses were given either a very low or a high dose of psilocybin. The high-dose group experienced a significant increase in meaning of life, optimism and quality of life as well as a reduction in fear of death compared to the low-dose group.

Reducing Substance Abuse

Researchers are studying whether psilocybin may be effective in helping people quit smoking, drinking, or substance abuse. In a small study, researchers looked at the use of psilocybin as a potential treatment for alcohol addiction and found that it helped reduce drinking and alcohol cravings. However, more research is needed to determine its effectiveness in larger populations.

In a pilot study, researchers found a significant improvement in the likelihood of smokers quitting after 12 months when treated with psilocybin. While there are some reports of psilocybin helping with other forms of substance abuse, more research is needed to determine its effectiveness in reducing cravings and drug use.

Diploma

The recent approval by Apex Labs Ltd of a comprehensive psilocybin study in 160 patients. marks a significant milestone in the growing acceptance of psychedelics as potential treatments for mental and behavioral disorders. With its double-blind, multi-site, placebo-controlled, and clinical SUMMIT-90 study, Apex aims to fill gaps in current macrodose studies and to evaluate the effects of repeated doses of their synthetic psilocybin in conjunction with psychotherapy on patients diagnosed with psilocybin major depression and PTSD.

If successful, the experiment could offer a new, improved therapy alternative. There is optimism that these studies will help pave the way for upcoming drug approvals and ultimately expand access to innovative therapy alternatives for those in need as the industry follows the development of Apex.

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