The Trajectory and Importance of Psychedelic Clinical Trials

At the end of June, COMPASS Pathways announced it had administered its patented psilocybin-derivative, COMP360, to 216 patients in the largest psilocybin assisted-therapy trial to date. The Phase IIb clinical trial is examining the safety and efficacy of COMP360 to combat treatment-resistant depression, with the results expected to be published later this year.

Clinical trials are an essential building block in the development of psychedelic medicine, as the data informs the FDA, and other regulators, on the drug’s safety and suitability for medical application. As a result, drug developers rely on this scientific evidence to secure regulatory approval and pave the treatment’s route to market. 

Blossom specialises in clinical psychedelic data using a unique digital platform that collates market intelligence from across the burgeoning sector. Compiling data from across the psychedelics industry into a comprehensive database allows analysts to translate the findings into actionable insights for stakeholders. This enables investors to make informed decisions on the market’s future, identifying imminent commercial opportunities, as well as clinical breakthroughs that could define the sector long-term. 

The progress of clinical trials and the emanating opportunities will be highlighted in PSYCH’s upcoming Psychedelics as Medicine Report: Third Edition, of which Floris Wolswijk, founder of Blossom, is a key contributor. In addition to co-authoring the report, Wolswijk sat down with PSYCH ahead of 7 July’s PSYCH Investor Summit: Research & Development to discuss clinical trials and how they shape the industry.

Why are clinical trials essential to legitimise psychedelic medicines?

Clinical trials are the foundation of psychedelic medicine, as they provide invaluable data on dosage, safety and efficacy. Phase I trials look at dosage, to find safety limits; Phase II trials investigate how well the treatment works in patients; and Phase III compares the drug against existing treatments on the market. Phase IV trials take place after it has been made widely available, and monitor responses to the medication over an extended period.

What is the market significance of COMPASS Pathways’ Phase II clinical trial?

COMPASS Pathways’ clinical trial is significant in that it was the largest to date to examine if a psilocybin-based drug could treat depression. As depression affects a large number of the population across the world, the results could revolutionise psychiatry. However, it’s important to remember that this is just a Phase II trial, so we’re only at second base, with more studies to be undertaken before the treatment is widely available. 

If we look at the work being done by MAPS, whose Phase III trial examining MDMA for treatment of PTSD is farthest along of any current clinical trial, we see how the FDA is responding and their approach to working with researchers. The evidence of MAPS’ experience so far shows positive indications for the process generally. 


How can investors and industry professionals access research data?

The results of clinical trials that impact the psychedelic industry, as well as data pulled from other sources, can be found on our website. The database contains over 1,200 research papers and 300 company profiles, with statistics edited for brevity and relevancy for stakeholders. An overview of this information will be published in PSYCH’s periodic Psychedelics as Medicine Reports, in a concise and comprehensive format for investors, regulators and decision-makers.

What are the upcoming clinical trials needed for the industry to reach its potential?

The number of clinical trials taking place is accelerating, but many more need to be done. 

The majority have taken place to combat depression and associated disorders, but early research indicates psychedelic medicines could have far wider benefits – for both mental and physical health. 

There needs to be far greater patient diversity, as ethnic minorities are currently heavily underrepresented. Only 2% are of Asian origin, which is concerning as the demographic accounts for the majority of the population. To promote global adoption, clinical trials need to more closely represent society so we can better generalise outcomes.

PSYCH Investor Summit: Research & Development

Wolswijk will share insights from Blossom’s psychedelic research database and The Psychedelics as Medicine Report, at the PSYCH Investor Summit: Research & Development on 7 July. The full agenda for the industry-leading event can be found here, with complimentary tickets still available.