The CEO of Compass Pathways said Wednesday that the company, which is preparing to complete the submission of its psychedelic therapy for regulatory review this quarter, will “go slow before we go fast,” warning that negative patient or provider experiences early in the launch could damage the broader sector.
As the psychedelics field races toward its first potential approval by the Food and Drug Administration, the executive, Kabir Nath, underscored that a cautious rollout would be essential. But he also said the mental health field was on the brink of a major change.
“I think this is a really big deal for patients, for providers, and incidentally for Compass Pathways as well,” Nath said, speaking in Boston at the STAT Summit.
Compass is preparing to complete a rolling FDA submission this quarter for COMP360, its synthetic psilocybin treatment for treatment-resistant depression, with aims to launch early next year.
Nath said the company expects its treatment, if approved, to be subject to an FDA risk evaluation and mitigation strategy, or REMS, and is investing in training for providers who would administer the drug.
Unlike conventional antidepressants, which can take weeks to work and require daily dosing, psilocybin has shown the potential to produce rapid and lasting improvements after just a handful of administrations, Nath said.
In Compass’s Phase 3 trials, roughly a quarter of patients experienced a clinically meaningful response after a single administration of COMP360, which involves a roughly six-hour supervised session. That figure rose to about 40% after a second dose three weeks later. Nath said the company’s longer-term data suggest that patients who respond to treatment can experience benefits lasting as long as a year after two or three administrations.
But Steven Hyman, a Harvard University professor and former director of the National Institute of Mental Health, cautioned that significant scientific questions remain about psychedelic treatments, including how to establish their efficacy in clinical trials.
One challenge is that patients who receive a psychedelic drug often know they have received it because of its distinctive effects, potentially compromising the blinding of trials. This was one concern when an MDMA-based therapy from Lykos Therapeutics was rejected by the FDA in 2024.
“The unblinding remains a challenging problem,” Hyman said.
He raised another fundamental question: whether the psychedelic experience itself is necessary for the drugs to work.
Some companies are developing compounds designed to produce antidepressant effects without hallucinations or other intense subjective experiences. If successful, such treatments could potentially be prescribed for patients to take at home, eliminating the need for lengthy supervised sessions.
“It would be nontrivial if you could separate these, because then somebody could write a prescription and send somebody home,” Hyman said. “But we don’t know.”
That question also has implications for psychotherapy, which has traditionally been considered an important component of psychedelic treatment.
Nath said Compass deliberately separated psychotherapy from its clinical trials, arguing that the company’s responsibility is to develop a drug rather than dictate how physicians provide psychological care. He noted that an analysis of recorded treatment sessions found that roughly 80% of the time was spent in silence.
Hyman said psychotherapy following a psychedelic experience could nevertheless help patients process powerful emotions, memories, and other psychological effects. But he emphasized that researchers have yet to determine how much of the clinical benefit comes from the drug’s pharmacological effects and how much from the experience itself.
The discussion also touched on the risks of moving too quickly to bring psychedelic treatments to market – particularly since officials in the Trump administration have expressed support for accelerating their development.
Hyman said the field’s credibility would depend on rigorous research, responsible marketing, and long-term safety monitoring.
“I don’t mean this as a pun,” Hyman said. “But being really sober about the way this research is presented — the only way to gain credibility is to be absolutely rigorous.”
He drew a comparison to cannabis, where early perceptions of safety did not anticipate all the risks associated with increasingly potent products.
Even if COMP360 wins approval, another major challenge will be ensuring that patients can afford and access the treatment.
Asked about potential pricing relative to Johnson & Johnson’s Spravato, an esketamine treatment for depression, Nath said Spravato provides a reference point but declined to commit to a specific pricing benchmark.
The treatment’s costs would extend beyond the drug itself, given the need for several hours of monitoring in a clinical setting. Nath said Compass has spent years working on reimbursement mechanisms for that monitoring and is engaging with commercial insurers and the Centers for Medicare and Medicaid Services to secure coverage.
For Hyman, the promise of psychedelics is clear, particularly given the limitations of existing depression treatments. But their emergence also underscores how much psychiatry still needs to learn about the biological underpinnings of depression and why patients respond differently to treatment.
“We’re awash in subjectivity still,” he said, pointing to the lack of objective biomarkers that could help researchers identify which patients are most likely to benefit from a given drug.
Source: www.statnews.com
