Compass Pathways isn’t your everyday startup. Barely a year after its incorporation in June 2016, it received £3 million in funding and was sitting down with the European Medicines Agency (EMA), roughly the equivalent to America’s Food and Drug Administration (FDA). It is now closing another round of investment, this time for £25 million ($33m), according to executive chairman and co-founder George Goldsmith.
But what makes Compass unique is its goal: to speed up evidence-based innovation for mental health treatments by researching, and potentially be the first to market the psychedelic substance psilocybin to combat treatment-resistant depression (TRD), which afflicts some 100 million people worldwide (NCBI).
Set up by Ekaterina Malievskaia and her husband George Goldsmith, Compass Pathways is weeks away from starting the largest clinical trials ever for TRD with psilocybin-assisted psychotherapy. Beginning in the UK in July before spreading to continental Europe over the summer, almost 220 patients will be given synthetic psilocybin, the active ingredient in magic mushrooms. Their results will be monitored over a three-month period and analyzed to figure out which of the proposed three doses – 1 mg, 10 mg, or 25 mg – is most effective. If successful, they will then move on to the final phase of clinical trials with another 180 patients, after which the EMA will have to decide whether to approve the potential treatment. Goldsmith told WikiTribune he hopes this will be around 2021.
“[Mental healthcare has] often been a poor stepchild of physical health,” said Goldsmith, seated in a room next to his company’s office in central London. For him, one of the key issues is providing tailored care for people suffering from mental health conditions.
Depression is the leading cause of disability worldwide; it affects over 300 million people, and increased almost 20 percent from 2005 to 2015, according to the World Health Organization (WHO). Anti-depressants are still the most common treatment. They are relatively effective (The Lancet) but come with damaging side effects. They don’t work for roughly a third of people (NCBI) suffering from treatment-resistant depression. In the UK, long waiting times for psychological counselling add an extra step for many people who may require treatment (The Independent) but can’t afford private healthcare.
Psilocybin-assisted therapy could break that impasse. In October 2017, researchers at Imperial College London published a study into the effects of psilocybin on people suffering from severe depression: it showed promising results. “We have shown for the first time clear changes in brain activity in depressed people treated with psilocybin after failing to respond to conventional treatments,” said Robin Carhart-Harris, head of psychedelic research at Imperial.
WikiTribune sat down with Compass Pathways’ Goldsmith to talk about his hopes for the company, and tackling TDR.
This interview has been substantially edited for clarity and length. Please see Sources and References for the full transcript.
WikiTribune: In the company principles, you say one of the things that drives Compass Pathways is the inconsistency of health systems’ responses to mental healthcare. Could you elaborate on this?
Goldsmith: When you look at that, then the question is, what are the quality of tools that we have? We do have, I think, really good medications for some people. We have different kinds of treatments. But we still have a large problem here. I think innovation is needed. I think the last really significant innovation in mental health is the invention of the antidepressants, but that was almost 30 years ago.
Can you tell us a bit more about the upcoming clinical trials, and go into why the triple blind process that you’re using for the trial is so important?
Goldsmith: The trial we’re doing right now is called a Phase II B Dose Control/Dose Finding Study, for patients with treatment-resistant depression. What someone wrote about this as triple blind, is not really a true medical distinction, it’s usually a double-blind placebo controlled trial. The blinding is important because you want to try to minimize bias from research. This is the real challenge. How do we have the patient not be biased as to what dose they might get? How have the people who are actually caring for them not be biased by thinking, “Oh, this person’s going to get this low dose and I have to prepare for that?”
The most critical piece of information is how depressed patients are. We collect that before they have the treatment, as well as at different time points for three months after the treatment. That’s administered remotely by someone who simply telephones, who has no idea what study the patients are in: what medicine they receive, it’s completely unknown to the person who’s actually rating it. They’re completely independent. This is really the gold standard of assessing, the scientific rigor that’s required. This is why we do that.
What stage are you at right now?
Goldsmith: The step that we’re in right now is called “dose finding”: what we want to do is come up with the optimal dose. Earlier studies have never done this to a regulatory standard. We imagine that we would be ready for review probably in 2021, but regulatory approval of a medicine is really the starting line of patient access, not the finish line. So then we have to work with all the health systems to make the case of why this should be available, its cost effectiveness, and that’s why we’re really committed to doing that work to make sure it’s available and cost-effective for governments.
It might be early days for this, but have you got a range estimate of how much treatment would cost, and whether that would be possible to access through publicly funded healthcare?
Goldsmith: Absolutely no idea how to accurately say how much it will cost, because we don’t know if it works. We don’t know if it’s one session or two sessions. There’s a lot of uncertainty. Our principles right now are simply to make it as accessible to as many people who have treatment-resistant depression as possible. That means we’ll have to price it lower rather than higher.
In the After On podcast, you said that you had raised $20 million?
Goldsmith: Well, we’re just closing on 25 million pounds. That was in addition to our initial £3 million of funding.
Are you still hoping to raise more funds, on top of the £25 million?
Goldsmith: The £25 million takes us through the completion of these studies, plus a variety of other studies we’re doing, to look at other potential indications, beyond depression. When we move to the final phase of research for the approval level, assuming this phase is successful, then yes, we’ll be raising more money at that time, but that’s probably a couple of years off.
How is Brexit factoring in to your funding or business plans?
Goldsmith: Our focus is on Europe and that we are – like every other organization in the UK – awaiting what Brexit will mean and then understand the implications of that. I think, like every other company, we just kind of try to manage living in a world of uncertainty, but I don’t see it as any kind of profound shift right now. Our goal is to be providing this care to people who need it no matter what country they’re in, that’s our real focus.
But are you planning for a hard Brexit [a potential scenario in which the UK leaves the European Union without a deal]?
Goldsmith: We quickly set up an organization in another country, move everything and continue on just like all the other companies are planning. I think the bigger issue that’s happening is from a research perspective; European funds and the consortia to use those funds simply aren’t looking to the UK any more because it’s just too risky.
Do you think that large pharmas might get involved in this or might purchase firms such as yours in order to grow?
Goldsmith: I think we’re so early on, we don’t have really solid evidence right now at scale, so it’s really hard to predict that. I think ours is a very, very different model than selling tablets that are administered day after day after day, which is the traditional pharmaceutical model. Now those models are changing in pharmaceuticals as well where countries that are really looking at the use of public funds.
Compass Pathways started off as a non-profit but is now for profit, correct? Can you tell us why?
Goldsmith: We started as a nonprofit because we thought that that could be done. But the promise was for really helping this large problem of 100 million people around the world, and when you get there you really have to look at how you scale.
What are your hopes for the company?
Goldsmith: From my point of view, what should happen with this company, if the science is correct, is that it should become a public company, a large global public company, caring for developing mental health improvement. There’s so many if’s between now and then, but I think if everything worked the way we would want, we’re going to be a standalone company that could govern and work according to our own principles and not try to fit into another organization.
What would you respond to researchers and experts, such as James Fadiman, who say that today’s scientific protocols are not so clear cut with psychedelics since there’s always a immeasurable subjective side. In other words, how do you quantify a subjective experience?
Goldsmith: Well, I mean that’s all that psychiatric research really has ever done, you could say. Now I do think that there’s a bigger question in what James and others say: is the gold standard of double-blind placebo control trials fit for purpose with psychedelics, and I think one can have a good debate about that. However, while we’re debating, there are patients who are suffering, and our view is that what we need to do is to do the best possible science we can, according to current principles and standards, while working with regulators on the models that they have.
See also WikiTribune reports: