Psilocybin, the primary psychoactive compound in “magic mushrooms,” has been associated with recreational drug use and 1960s counterculture. However, recent research over the past two decades has shown that it can potentially treat various mental and behavioral health disorders.
Health Canada has approved a comprehensive psilocybin trial on 160 patients, including macro and multi doses, by Apex Labs Ltd. This Canadian biopharmaceutical firm is also advancing at-home psilocybin microdose studies and supporting veteran patients. The trial has been deemed “statistically powered.”
SUMMIT-90
The company’s Phase 2b study, known as SUMMIT-90, is a double-blind, multi-site, placebo-controlled, and in-clinic trial. It evaluates the impact of repeated macrodoses of its synthetic psilocybin APEX-90, coupled with exclusive psychotherapy, on participants diagnosed with severe depression and PTSD.
To address gaps in current macrodose studies, a precise dose has been chosen for administration in multiple doses over three months. The entire investigation, including screening, recruitment, treatment, and post-treatment effects measurement, is anticipated to last for a year.
Patient recruitment for the trial is set to begin sometime this quarter. The primary indication for the trial is a severe depression within PTSD, while the secondary indications include chronic pain, anxiety, and standalone PTSD symptoms. The severity of symptoms will be measured through scales that assess changes from baseline.
Tyler Powell, co-founder, and CEO of Apex, stated that the approval from the federal agency confirms the urgent requirement for enhanced healthcare alternatives. Dr. Peter Tomlinson, the CMO, further added that the dosing schedule for this trial had been optimized for sustained efficacy, focusing on patients suffering from the most severe form of the disease.
Following a successful proof-of-concept clinical study, Apex has optimized its proprietary psychedelic compound for treating mild-to-moderate depression in its ongoing Phase 2b trial, PATHFINDER-52. The trial involves take-home microdoses of psilocybin. Dosing for this trial is expected to commence by mid-2023. Centricity Research will be conducting both SUMMIT-90 and PATHFINDER-52 trials across five sites in Canada.
Apex’s Commercial Path
Greg Rutherford, Apex CCC, revealed to Benzinga the commercial pathway that the company intends to pursue, which involves:
- Exhibit significantly enhanced clinical and patient outcomes compared to current standards of care in treating standalone depression and anxiety, as well as depression and anxiety with diagnosed PTSD. This enables the eventual approval of a broad and optimal treatment label.
- Optimize access to their treatment resources by securing regulatory approvals in the U.S., Canada, Australia, and the EU, along with commercial listings and drug reimbursement.
- To generate awareness about their drug assets and ensure that the right patients can access treatment. Apex plans to collaborate with crucial treatment stakeholders and develop additional tools and programs.
Given his extensive background in big pharma, Rutherford anticipates that once enrollment for both clinical trials begins, health industry stakeholders will notice the company. If the endpoints are met, and the outcome data is compelling, these stakeholders will analyze the study results and, if appropriate, initiate further action.
According to Rutherford, the pharma industry typically seeks to acquire drug assets after Phase 2b trials. Subsequently, they plan and conduct pivotal clinical Phase 3 trials using their clinical and regulatory infrastructure and commercial expertise. This means they aim to acquire assets offering significant commercial potential at a Phase 2 price.
Benefits of magic mushrooms
The notion that psilocybin has no medical applications is not supported by scientific evidence is not true. While further research is required, strong evidence suggests that psilocybin has therapeutic benefits within the mental health field. Some therapeutic benefits of psilocybin include;
Depression
During a study conducted in 2022, a group of researchers examined the impact of psilocybin on 27 individuals who had suffered from depression for an extended period. The study involved administering two doses of psilocybin to each participant every two weeks between August 2017 and April 2019.
The study revealed that the subjects’ depression scores remained low after 1, 3, 6, and 12 months following the treatment. While this is encouraging, the researchers highlighted the need for further investigation to understand the connection between psilocybin and depression fully. Specifically, it is essential to determine if the benefits of the treatment can be sustained beyond 12 months.
Post-traumatic stress disorder (PTSD)
A study on mice showed that low doses of psilocybin effectively conditioned the fear response. This could imply that magic mushrooms can potentially treat PTSD and similar conditions. However, further research on humans is required to confirm this connection.
Furthermore, research indicates that the psychological impact of psilocybin can be uncertain, making it challenging to determine the effectiveness of magic mushrooms as a treatment for PTSD with absolute certainty.
Anxiety
Further research is necessary to determine the efficacy of psilocybin in treating anxiety, but preliminary studies show promising results. In a 2016 study, 51 cancer patients with life-threatening diagnoses were administered either a very low or high dose of psilocybin. The high-dose group experienced a significant increase in life meaning, optimism, and quality of life, as well as a reduction in death anxiety compared to the low-dose group.
Reduction In Substance Misuse
Researchers are investigating whether psilocybin can be effective in helping individuals quit smoking, drinking, or misusing drugs. In a small study, researchers looked at the use of psilocybin as a potential treatment for alcohol dependence and found that it helped to reduce drinking and alcohol cravings. However, further research is needed to determine its efficacy in larger populations.
In a pilot study, researchers found a significant improvement in the likelihood of smokers abstaining after 12 months when treated with psilocybin. While there are some reports of psilocybin helping with other forms of substance misuse, more research is needed to determine its effectiveness in reducing cravings and drug use.
Conclusion
The recent approval of a comprehensive psilocybin trial on 160 patients by Apex Labs Ltd. marks a significant milestone in the growing acceptance of psychedelics as potential treatments for mental and behavioral health disorders. With their double-blind, multi-site, placebo-controlled, and in-clinic SUMMIT-90 trial, Apex aims to address gaps in current macrodose studies and evaluate the impact of repeated doses of their synthetic psilocybin coupled with psychotherapy on patients diagnosed with severe depression and PTSD.
If successful, the experiment might provide a fresh, improved therapy alternative. There is optimism that these trials will help pave the way for upcoming drug approvals and ultimately expand access to cutting-edge therapy alternatives for those in need as the industry keeps track of Apex’s development. (Full Story)