psilocybin, which is the primary psychoactive compound in “magic mushrooms”, and has been associated with recreational drug use and the counterculture of the 1960s. However, recent research over the past two decades has shown that it can potentially treat many mental health and behavioral disorders.
Health Canada approved a comprehensive 160-patient psilocybin trial, including large and multiple doses, by Apex Labs Ltd. This Canadian biopharmaceutical company is also getting ahead at home Studies of small doses of psilocybin Veteran patient support. The trial was deemed “statistically supported”.
The company’s Phase 2b study, known as SUMMIT-90, is a double-blind, multisite, placebo-controlled, in-clinic trial. evaluates the effect of repeated high doses of synthetic psilocybin APEX-90, along with exclusive psychotherapy, on participants diagnosed with Severe depression and post-traumatic stress disorder.
To address gaps in the current large-dose studies, a precise dose selection was made for administration in multiple doses over a period of three months. The entire investigation, including screening, recruitment, treatment and measurement of post-treatment effects, is expected to last a year.
Patient recruitment for the trial is scheduled to begin sometime this quarter. The primary indication for experience is severe depression in PTSD, while secondary indicators include chronic pain, anxiety, and independent PTSD symptoms. Symptom severity will be measured by scales that assess changes from baseline.
Apex co-founder and CEO Tyler Powell stated that the approval from the federal agency underscores the urgent need for improved healthcare alternatives. Dr. Peter Tomlinson, chief marketing officer, added that the dosing schedule for this trial has been optimized for sustained efficacy, with a focus on patients with the most severe form of the disease.
Following a successful proof-of-concept clinical study, Apex has optimized its proprietary psychedelic compound to treat mild to moderate depression in its ongoing Phase 2b trial, PATHFINDER-52. The experiment involves taking small doses of psilocybin at home. Dosing for this trial is expected to begin by mid-2023. Centricity Research will conduct trials of both SUMMIT-90 and PATHFINDER-52 across five sites in Canada.
Apex Trade Track
Greg Rutherford, Apex CCC, Benzinga revealed The commercial path that the company intends to follow, which includes:
- Offer significantly improved clinical outcomes and patient outcomes compared to current standards of care in the independent treatment of depression and anxiety, as well as depression and anxiety with a diagnosis of PTSD. This enables final approval of a broad and optimal treatment label.
- Improve access to their treatment resources by securing regulatory approvals in the United States, Canada, Australia and the European Union, along with trade listings and drug reimbursement.
Given his extensive background in major pharma, Rutherford expects that once enrollments in both clinical trials begin, health industry stakeholders will take notice of the company. If the endpoints are met, and the outcome data is compelling, these stakeholders will analyze the results of the study and, if appropriate, initiate further action.
According to Rutherford, the drug industry typically seeks drug assets after Phase 2b trials. Next, they plan and conduct pivotal Phase III clinical trials using clinical, regulatory infrastructure, and commercial expertise. This means that they aim to acquire assets that offer great trading potential at a Stage 2 price.
Benefits of magic mushrooms
The notion that psilocybin has no medical applications that are not supported by scientific evidence is incorrect. While more research is needed, strong evidence indicates that psilocybin has therapeutic benefits in the field of mental health. Some of the therapeutic benefits of psilocybin include:
During a study conducted in 2022, a group of researchers examined the effect of psilocybin on 27 individuals who had suffered from depression for a long time. The study involved giving each participant two doses of psilocybin every two weeks between August 2017 and April 2019.
The study revealed that the subjects’ depression scores remained low at 1, 3, 6, and 12 months after treatment. While this is encouraging, the researchers highlight the need for more investigation to fully understand the relationship between psilocybin and depression. Specifically, it is necessary to determine if the benefits of treatment can be sustained beyond 12 months.
Post-traumatic stress disorder (PTSD)
A study in rats showed that low doses of psilocybin effectively affect the fear response. This may indicate that magic mushrooms can treat post-traumatic stress disorder and similar conditions. However, more research in humans is needed to confirm this link.
Furthermore, research indicates that the psychological effect of psilocybin can be uncertain, making it difficult to determine with certainty the effectiveness of magic mushrooms as a treatment for PTSD.
More research is necessary to determine the effectiveness of psilocybin in treating anxiety, but preliminary studies show promising results. In a 2016 study, 51 cancer patients with life-threatening diagnoses were given either a very low or 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 decrease in death anxiety, compared to the low-dose group.
Reducing substance abuse
Researchers are investigating whether psilocybin is effective in helping people stop smoking, drinking, or drug abuse. In a small study, researchers looked at the use of psilocybin as a possible treatment for alcoholism and found that it helped reduce cravings for alcohol and alcohol. However, more research is needed to determine its effectiveness in a larger population.
In a pilot study, researchers found a significant improvement in the likelihood that smokers would quit smoking 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 drug cravings and substance abuse.
The recent approval of a comprehensive 160-patient psilocybin trial by Apex Labs Ltd. A landmark in the growing acceptance of drugs as potential treatments for mental health and behavioral disorders. Through the SUMMIT-90 double-blind, multisite, placebo-controlled, in-clinic trial, Apex aims to address gaps in existing large-dose studies and to evaluate the effect of repeated doses of synthetic psilocybin combined with psychotherapy on patients diagnosed with major depression and ADD after shock.