UK-based COMPASS Pathways recently published data from its Phase IIb trials, with COMP360 psilocybin therapy for treatment-resistant depression. This follows the release of the design for the company’s pivotal Phase III trials, the first-ever Phase III psilocybin therapy trial and the final studies prior to market approval.
With the treatment’s regulation anticipated in 2025, PSYCH sat down with COMPASS Pathways’ CEO, Kabir Nath, to discuss the organisation’s commercialisation strategy and the economic outlook for 2023.
At the start of November, COMPASS reported a cash position of US$175 million. PSYCH asked the CEO whether this would be enough to deliver COMP360 psilocybin therapy to market.
‘That money gives us runway into 2024,’ recognised Nath. ‘But we will need to fundraise in order to get to commercialisation.
‘The market environment is challenging; however, we recently published Phase IIb data in the New England Medical Journal, which is a real validation of the work. When talking with investors, there is a real appreciation for the robust studies we have designed for our Phase III trials, and COMPASS is seen as a leading company in the sector.
‘So, despite the challenging environment, we will continue to take those same messages to investors – about the data and robustness of the programme. We have generated confidence that the Phase III trials will generate similar data, and if successful we are confident that we will get regulatory approval.’
COMPASS has a number of milestones and inflection points anticipated within the next few years, notably the release of data from Phase III trials. As the company progresses to the final stages of drug development, Nath outlined the organisation’s commercialisation strategy.
‘The principal focus of our work has been on North America, although we are looking at Europe as well. I think it is important to understand a couple of key elements. There is the provision of COMP360 psilocybin itself, which will be prescribed by a psychiatrist and then administered at a treatment centre.
‘In the US we have started to identify the types of treatment centres to provide those services. There is a growing sector for interventional psychiatry, particularly with esketamine, so we have started to talk with companies about their openness to add psilocybin therapy to their range of services.
‘We have found them to be very receptive and, over the next couple of years, in parallel with Phase III studies, we will be continuing to work with some of those commercial entities to support the administration of COMP360 psilocybin therapy.
‘At COMPASS we are not going to be making investments in treatment centres or hiring therapists; instead, our revenues will come from the drug side. Practically speaking, we are ensuring that our investment goes towards our core strength, drug development.
‘There are other companies better placed to build out the supply side; however, it is critical from the patient’s perspective that the treatment journey is seamless. So, we are doing the work to ensure a seamless experience from the psychiatrist to therapist and treatment centre. This, in parallel with Phase III trials, will be a big part of our efforts in the next couple of years.’
As share prices and investments slump across the sector, an industry shakeout is taking place characterised by a rise in M&A activity. PSYCH was interested to learn if COMPASS was looking at early-stage trials for opportunities to expand its intellectual property.
‘It is a great question,’ said Nath. ‘We have done deals to acquire IP in the past. I think it’s important that over time COMPASS develops a broader portfolio of products. We have our own discovery efforts, with our COMPASS Discovery Centre, and an in-house team that works on novel mechanisms and novel routes of administration. However, we would definitely be open to external developed products for the right opportunity.’
With market volatility expected to continue throughout 2023, PSYCH asked Nath how COMPASS was ensuring stability in these turbulent times.
‘We are focused on what we need to do. Our number one priority is executing Phase III trials for treatment-resistant depression. We ran very successful Phase II trials across 22 sites in 10 countries with 233 patients.
‘We are building on this experience to expand Phase III studies to include close to 1,000 patients. As an organisation we have demonstrated we can conduct robust clinical trials, but this will be on a bigger scale with more sites, more therapists and more patients. The process to scale from Phase II trials to Phase III trials is already underway and I’m confident we can do that.
‘Secondly, it is important to demonstrate the potential breadth of COMP360 in mental health, so we will be pushing forward to complete two other Phase II trials by the end of 2023 – to treat PTSD and anorexia nervosa. Treating anorexia in particular has struck a significant chord with many in the community. There is no approved drug for anorexia and it is a serious mental illness with the highest rate of mortality.
‘It is important to build out commercial capabilities, but in the next couple of years the strategy will be focused on building relationships, not commercial infrastructure. Unfortunately, you are absolutely right. It is going to be a challenging market environment for the foreseeable future. We have a very strong and experienced management team focused on our priorities and what we need to do.’