This morning, Compass Pathways announced that it now expects to provide a top-line readout from its first phase 3 study (COMP005) of its psilocybin candidate (COMP360) in treatment-resistant depression (TRD) in Q2’25, and a readout from its second, two-dose phase 3 study (COMP006) in H2’26.
The company also announced a corporate restructuring that sees it shed nearly a third of its workforce along with its preclinical programs and digital tools.
COMP005: Recruitment and Logistics Difficulties Delay Readout
The first readout from Compass’ phase 3 program was originally slated for this summer, before being pushed back to Q4’24. More recently, the company said that readout could be pushed back to January 2025. So, today’s announcement of a further delay to Q2’25 is substantial.
The primary culprit for the delay is slower-than-expected recruitment and logistical difficulties, company execs say.
Speaking on a conference call held earlier today, CEO Kabir Nath said that the company had largely based its recruitment projections on its phase 2b study, but now realises this was a tad optimistic. He emphasised that the company has dispatched its Chief R&D Officer, Michael Gold, to trial sites where he is identifying and resolving pain points, where possible. “This hands-on approach is working”, Nath told investors.
In terms of what we might expect to see in the eventual COMP005 readout, Nath cautioned that the 6-week data will be limited, as the trial is blinded through the 26-week period.
We should expect to see three key efficacy measures (MADRS differences between arms, p values, and confidence intervals) and a basic, high-level assessment of safety from the independent Data and Safety Monitoring Board (DSMB).
There will be no detailed safety tables, Nath said, “as that would require unblinding”. “The DSMB will comment on whether they’re seeing any imbalance in suicidal ideation”, Nath added, but could not provide hard metrics on what might constitute an imbalance, instead deferring to the DSMB.
COMP006: Functional Unblinding Concerns and Recruitment Speed Conspire to Delay Readout
But even more substantial is the modified guidance for the company’s second readout, which Compass recently said was on track for a mid-2025 readout but has now been pushed back to the latter half of 2026; a delay of at least a year.
Speaking to Psychedelic Alpha, Nath said that this delay is the result of an internal decision to do everything it can to assuage FDA’s concerns regarding functional unblinding.
Nath raised the Lykos AdComm and NDA submission process several times on today’s conference call, which he said “provided key insights into the FDA’s thinking and some of the challenges faced by this new class of drugs.”
While Nath characterised the majority of the agency’s concerns as Lykos-specific, he singled out the “high degree of scrutiny on functional unblinding”, which he described as “very relevant to our trials.” And, should it reach the point of NDA submission, the topic will be front and centre from both the agency and its advisors at an anticipated AdComm of its own.
The company has put in place trial design features that it hopes would minimise the prevalence and impact of functional unblinding, such as using three dose levels of psilocybin (25, 10, and 1 mg) in its COMP006 trial and limiting the portion of participants who disclose prior use of psychedelics to 15% of the sample.
But today’s announcement reveals that the company has made “the very difficult decision” to push back the top-line readout until patients have passed through the entire 26-week blinded portion of the study, Nath said. Originally, the company had planned a readout of its 6-week primary endpoint, as in COMP005. The decision was an internal one, and not the result of new FDA guidance or recent discussions with the agency, according to the CEO.
Basic math suggests that this decision alone pushes the timeline back nearly half a year… but certainly not a full year or more.
On that note, Nath conceded that the new guidance reflects not only this readout timing adjustment, which Nath told us is what the company believes to be “the best and most strategic decision”, but also a tempering of the company’s broader expectations of recruitment pace. “There is still some uncertainty around the recruitment curve”, Nath said.
It’s also the case that some COMP005 trial sites are expected to ‘roll over’ into COMP006 sites as they wind down recruitment on the first study, so the delay to that initial study will have some knock-on effect on COMP006 timelines. And, given the more complex two-dose, three-arm protocol of COMP006, logistical complexities are only expected to be compounded…
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