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…