Earlier this month in Madison, Wisconsin, Psychedelic Alpha’s Josh Hardman sat down with Compass Pathways’ Chief Patient Officer, Steve Levine, at a pivotal time for the company. Just a week prior, the psilocybin drug developer told investors it is bringing forward its commercialisation timeline by up to one year, following a “positive” September meeting with FDA and faster-than-anticipated enrollment in its second, larger Phase 3 study. Assuming that momentum holds, Compass is likely to deliver the first FDA-approved psilocybin therapy.
In this wide-ranging discussion, the pair cover these commercialisation-related topics, from the clinical infrastructure and credentialing through to comps and competition.
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In this Interview
- Durability
- Short-acting psychedelics
- Patient and provider experience
- Spravato infrastructure readiness and staffing
- Label and REMS-related considerations
- Real-world effectiveness and label expansion
- Predicting responders
- Comps
- Monotherapy and adjunct
- Launch geographies
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Durability
Josh Hardman: When it comes to the durability of COMP360’s effects, what would the company consider clinically and commercially meaningful?
Steve Levine: To be honest, although I think we expect durability longer than this, merely showing the effect size we did at week six after a single administration [in the Phase 3 study COMP005] is already completely game-changing.
There’s only one pharmacologic product being prescribed to people with [treatment-resistant depression (TRD)] today, Spravato. If you don’t have maintenance treatment with that, either weekly or every other week, you relapse. What we showed at week six would take ten treatments with Spravato: we had the same effect size at week six after one treatment as it had at week four after eight. So I know that there are a lot of opinions out there about what our durability should be, but I think it’s missing the point.
Short-acting psychedelics
Hardman: Does that hurdle for clinical and commercial relevance change if one of these shorter-acting drugs comes to market?
Levine: I mean, in some ways, it assumes it’s zero-sum. There were three to four million patients with TRD last year. About 60,000 of them got Spravato. This is a terribly underserved large patient population.
And it’s essentially chronic disease management. The rule is that patients at some point are going to relapse. Sadly, there is no cure, and so the likelihood is that people will wind up having multiple of these treatments over time.
We will most likely have been on the market for a few years before there are new competitors. But at that point, I would expect that the same sites that deliver COMP360 will also deliver some of the shorter-acting treatments…
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