Earlier this month, we completed the final psilocybin administration session for the last patient on our phase IIb study of psilocybin therapy for treatment-resistant depression. The study exceeded its target enrolment of 216 patients, with 233 participants across 10 countries in Europe and North America, and we expect to report results later this year.
We spoke to Sue Stansfield, Senior Vice-President of Clinical Operations at COMPASS, and Sam Williams, Project Manager of Clinical Operations at COMPASS, to find out what it was like to run a clinical trial in the middle of COVID.
Congratulations on successfully completing recruitment! What does this milestone mean to you personally and to COMPASS?
Sue – Thanks! It’s the culmination of four years’ work at COMPASS and a huge milestone in completing the largest, most rigorous clinical trial of psilocybin therapy ever conducted. It has been a massive team effort, involving hundreds of people – investigators, raters, study coordinators and nurses, therapists, and pharmacists, at 22 sites in 10 countries, as well as our supply chain and clinical research partners, and all the patients who participated. I’m really proud of what we’ve achieved.
Sam – Personally it’s been a great journey and one that isn’t over yet, as the final patients are still completing their follow-up assessments. There have been achievements along the way that made me feel like anything was possible, but also more challenging times that left me feeling the opposite – though these were a lot less frequent! Overall, it has been amazing and I have worked with incredible people within the clinical operations team at COMPASS, as well as with our many partners on the trial. We’ve all really pulled together to make completing recruitment a reality.
How did COVID-19 impact the trial, and what steps did you take to mitigate this?
Sue – We placed a stop on patient screening at all sites on 23 March 2020 as countries started to lock down. This was a tough decision, but it was the right thing to do. We did as much as we could remotely, but it was a difficult and frustrating time for everyone involved.
We reopened sites when local requirements for infection control allowed us to execute our protocol, which involves three people being in the same room for up to eight hours. This was important because we didn’t want to overburden people with PPE that could influence the quality of the patient’s psychedelic experience. The safety of patients and of our teams has always been our first priority, so extra measures such as air filtration units and therapists wearing clear masks were introduced to make sure patients were as comfortable as possible in the midst of all the COVID precautions.
Sam – We kept in regular contact with all the sites and each site was reopened, over a staggered period, only when we had all the necessary approvals and, importantly, when everyone involved was comfortable for us to do so.
What were some of the other challenges you faced in running this trial?
Sue – As the first clinical trial of this size and scope, we faced multiple challenges that no-one had encountered before, like providing clinical training opportunities for the therapists, gaining individual country approvals to ship and store COMP360, and equipping the treatment rooms at every site around the world with the same furniture and music systems.
What have you learned from running the trial?
Sue – That with enough persistence, you can achieve anything when you are working to benefit patients. Also, “it takes a village …”!
Sam – You can do all the planning but you have to remain flexible when unexpected things happen. We didn’t factor a pandemic into our recruitment plans …
What happens next?
Sue – Now that the last patients have had their psilocybin session, the site teams will continue to collect their data for the next 12 weeks. Once this has been completed, data analysis begins. We’ll be comparing the safety and efficacy of psilocybin therapy for three groups of patients, who were randomised to receive a single dose of 1mg, 10mg or 25mg of COMP360 psilocybin, in conjunction with psychological support. We expect to share results later this year.
If we are able to identify the optimal dose of COMP360 from this phase IIb study, then we will go on to conduct the phase III pivotal programme. The outcome of the phase III study would allow regulators and payors to consider marketing approval, and if successful, to become available to patients on a large scale.