COMPASS Pathways has attracted significant attention to the psychedelics space, with its September 2020 IPO making it the first billion-dollar psychedelic company. The company is focussing on psilocybin for treatment-resistant depression, with results of a Phase 2b clinical trial expected next year.
Given this timeline, and the large volume of funding the company has enjoyed, COMPASS is ahead of most other companies in the space in terms of clinical trial progress.
We spoke to Lars Wilde, President, Chief Business Officer and Co-founder of COMPASS. We pressed Wilde on how the company will remain competitive in the context of its nonprofit peers such as the Usona Institute, and against the backdrop of increasing decriminalisation and legalisation of psychedelics (and associated therapy) that does not rely on regulatory approval.
Psilocybin Alpha (PA): To begin, could you tell us how you personally became interested – and involved – in psychedelics, and COMPASS?
Lars Wilde (LW): I am an entrepreneur and have helped to start and build a number of companies, some in healthcare, some not. Several years ago, I suffered badly with treatment-resistant depression and anxiety, brought on by the sudden death of a close friend and colleague, and a number of other issues. I was put on various antidepressants, nothing worked. Eventually, one of my investors suggested psilocybin. I had a really positive experience with psilocybin mushrooms and have been rid of my depression and anxiety ever since. I knew I was lucky that this worked for me – I didn’t have a tested form of psilocybin in a therapeutic setting with support from a trained therapist, and there were many things that could have gone wrong! This led me to wanting to find some way to bring psilocybin therapy to others, and serendipity brought me to meeting George and Katya, COMPASS co-founders.
COMPASS isn’t just about psilocybin therapy, it’s about bringing evidence-based innovation in mental health to as many people in need, as quickly as we can. We are a mental health care company and we want to transform mental health care because what exists today is not good enough for so many people. The unmet need is huge – in depression alone, 100 million people suffer with treatment-resistant depression and don’t respond to existing medicines.
PA: On the most recent earnings call, George Goldsmith explained that COMPASS has chosen not to share interim results for the Phase 2b COMP360 trial. Why was this decision taken?
LW: Including an interim analysis always involves a loss of statistical power and therefore the need to increase final patient numbers to contribute to the final study analysis. We feel it would be more helpful to complete the full study as quickly as possible, randomising 216 patients.
PA: How do you intend to remain competitive amid a wave of decriminalization, and in some cases legalization, of psychedelics and associated therapeutic offerings? Measure 109 in Oregon, for example, allows for a diversity of modes for accessing psilocybin which diverge from conventional medical settings. How will COMPASS seek to remain competitive in this context?
LW: There are a number of different things to consider here.
Decriminalization measures are largely connected with recreational use of naturally occurring psilocybin. This is very different from what we are doing, which is developing psilocybin therapy for those in medical need. We agree that people should not go to jail for possessing ‘magic mushrooms’.
Legalization is different from decriminalization. We share the long-term goals of those involved in legalization efforts such as Oregon’s Measure 109 – we all want to help those with mental health challenges who don’t have other options. The Oregon measure provides for a two-year development period in which a state licensed system will be created to provide psilocybin therapy. However, regulators believe there isn’t enough evidence yet of the safety and efficacy of psilocybin therapy. And it is not clear who would pay for the therapy.
What we are doing at COMPASS is developing our COMP360 psilocybin therapy through clinical trials. We believe that review and approval through regulatory agencies is the best way to ensure the safety, efficacy and quality of any medicine or therapy. COMP360, our proprietary formulation of synthetic psilocybin, is being developed to meet the quality criteria associated with the regulatory standards for a medicinal therapy. And our commitment to patient safety includes rigorous training of licensed therapists who provide support to patients in our FDA-approved clinical trials. As to who pays – clinical evidence and regulatory approval will be prerequisites for any reimbursement consideration. So the regulatory route is the safest and most effective way to get psilocybin therapy (if approved) into the health system, reimbursed, and made available to all who might benefit from it.
PA: And, the same question vis-à-vis your non-profit peers: how do you plan to remain competitive versus Usona Institute’s commitment to licencing any psilocybin patents at cost (or even free), for example?
LW: We can’t comment on anyone else’s strategy or plan. We believe our business model enables us to fund the R&D activities necessary to bring psilocybin therapy to market and to generate the evidence required for reimbursement, as well as to develop new therapies and digital technologies that will complement and augment our therapies. Our goal is to build a sustainable and competitive business that will accelerate patient access to evidence-based innovation in mental health.
PA: Do these two pieces of context – legalization of psilocybin therapy and the work of peers – not threaten your economic moat, of which IP plays a central role?
LW: We are in the middle of a major global health crisis – the mental health care crisis. There is a huge unmet need, with 322 million people suffering with depression and over 100 million of those with treatment-resistant depression. It is likely that more than one approach may be needed to address this.
We believe our model offers the best way to help as many people, safely and effectively, as quickly as possible. IP does play a central role in this. It protects the significant investment that is required to take a potential therapy through rigorous large-scale clinical trials, by offering a return to investors. Without protection of our innovation, there would be little incentive to take the risk to fund the research and development of new products, given the large number of candidates that fail during the development process.
PA: ATAI Life Sciences just closed a $125 million Series C round. Which of ATAI’s portfolio companies does COMPASS collaborate with regularly, and is there any further collaboration between companies planned for the future?
LW: ATAI are one of our investors and have always been a great supporter. We share a passion for bringing innovation to mental health care and our goals are closely aligned, but we are not part of their operating platform and we don’t collaborate with any of their companies.
PA: Is COMPASS seeking to improve or modify COMP360 at all?
LW: We are always interested in how we can improve our manufacturing process and how we can create even greater efficiencies for supply and even higher quality. There are no specific plans for modification.
PA: It’s understood that COMP360 won’t be available to the public until 2025 at the earliest. This will require a great number of trained therapists to deliver therapy sessions. With this timeline in mind, when does COMPASS plan on rolling-out aforementioned “centers of excellence” where therapists will be trained?
LW: Our Centers of Excellence will be research facilities and innovation labs rather than therapist training centers, although therapist training will take place here too. The centers will model the clinics of the future and will be used to generate evidence to shape our therapy model, and prototype technology solutions to improve patient experience and support therapists. We expect the first Center of Excellence to be opened in the US shortly.
PA: Does COMPASS have any plans to manufacture its own psilocybin, or will it continue to rely on third parties to manufacture COMP360?
LW: We have no plans to establish our own manufacturing facilities, and work closely with our manufacturing and supply partners.
PA: Does COMPASS have plans to leverage digital health solutions in order to optimise treatments on a patient-by-patient basis?
LW: We are developing a portfolio of digital health and AI technologies and believe that prediction, prevention, and precision will be critical to the future of medicine and mental wellbeing. We want to get patients well and to keep them well. Digital technologies could be used to monitor how patients feel and behave, and potentially to detect early signs of post-treatment relapse.
PA: What are the company’s biggest risks in the next five years?
LW: Clinical drug development is always a risk. The number of therapies that fail at this stage is high, the investment is significant, and there are no guarantees. But psilocybin therapy has shown promising signals in early studies and we believe that generating evidence through rigorous clinical trials is necessary to gain regulatory approval and integration into health systems through reimbursement or other payor mechanisms. It’s certainly not without risk but in the face of today’s mental health crisis, we believe it’s a risk worth taking.