Compass Pathways Performs Phase III Clinical Trials with Synthetic Psilocybin
Synthetic Psilocybin from Compass Pathways
Compass Pathways, a prominent psychedelic biotechnology company, is currently leading a charge in clinical research with psilocybin, the psychoactive component of magic mushrooms, for therapeutic use. They have conducted multiple phases of clinical trials using synthetically derived psilocybin, COMP360.
Overview of Compass Pathways
Established in 2016, Compass Pathways has emerged as a pivotal player in psychedelic research, specifically targeting the therapeutic potentials of psilocybin. Their synthetic psilocybin formulation, COMP360, has earned the FDA’s Breakthrough Therapy designation for its potential in treating Treatment-Resistant Depression (TRD). They are currently engaged in phase III clinical trials, testing COMP360’s safety and efficacy. Despite a recent shakeup in leadership, caused by the departure of the Compass Pathways founders from the Board of Directors, they reportedly remains steadfast in pushing forward their research and gearing up for potential market introduction of a new pharmaceutical.
Questions and concerns remain about the efficacy of COMP360, it’s commercial viability and some consider the company to be overvalued, suggesting that they would need to capture 100% of the Treatment Resistant Depression market.
Synthetic vs. Natural Psilocybin
Compass Pathways has used synthetically derived psilocybin, maintaining that it allows for precise dosing and consistency, crucial for maintaining the integrity of clinical trials. These clinical trials have been progressing rather well and Compass Pathways has patented their formula. Further, it's noteworthy that they often use the term "psilocybin" generically when publishing their research findings, which may lead to misconceptions about its synthetic nature.
Recent research from Hebrew University of Jerusalem indicates potential advantages of natural psilocybin extracts in promoting synaptic plasticity, critical for long-term mental health benefits.
Is Natural Psilocybin more effective than Synthetic Psilocybin?
Synthetic psilocybin has shown promising results, however recent research finds that naturally occurring psilocybin may be more effective, due to how additional naturally occurring compounds may interact.
Read more.
Impacting Legal and Ethical Frameworks in Psilocybin Therapy
Compass Pathways has been instrumental in influencing policy changes, securing the FDA's Breakthrough Therapy designation, and establishing a CPT III code with the American Medical Association for standardized psilocybin therapy billing. These are major milestones in research, to be sure.
However the company has been criticized for aggressively pursuing patents, including attempts to patent basic therapeutic practices like "holding a patient's hand" during sessions. This is seen as unethical and harmful to the broader development of psychedelic therapies.
Personalization of Treatment
Compass Pathways champions a personalized treatment model that integrates synthetic psilocybin with tailored psychological support. However, their administration approach is largely shaped by controlled clinical protocols developed with institutions like Johns Hopkins University, aiming for reproducible outcomes across diverse patient populations. Some however, have suggested that this requirement may impact the commercial viability of the treatment.
Compass Pathways borrows their clinical approach from John Hopkins University
This includes patients reclining in a bed with a blindfold and headphones for the duration of their psilocybin experience.
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Synthetic Pharmaceutical Drugs versus Oregon’s Lab Grown Mushrooms
Compass Pathways focuses on synthetic psilocybin, while Oregon’s adult-use model provides a framework for manufacturing naturally occurring psilocybin in Psilocybe Cubensis mushrooms.
Stable Pathways Group and Lucid Cradle, operating within the Oregon Health Authority regulatory framework, and providing lab-grown, lab-tested magic mushrooms, believes in the intrinsic qualities of natural psilocybin and a maintains a philosophy of personalization and accessibility. We also oppose the frivolous patenting efforts and restrictions or limitations that could be placed on the emerging industry at its outset.
These contrasting approaches highlight ongoing debate and exploration in psychedelic-assisted therapy. As research progresses and regulatory frameworks evolve, the role of both synthetic and natural psilocybin in mental health treatment continues to be a critical topic for discussion among healthcare providers, policymakers, and ethical bodies.
Reach out to us to book a consultation and learn more about Psilocybin Services at Lucid Cradle.
