Compass Pathways CEO Kabir Nath said Wednesday that the company will "go slow before we go fast" as it prepares to complete a rolling FDA submission for COMP360, its synthetic psilocybin treatment for treatment-resistant depression. Speaking at the STAT Summit in Boston, Nath said the company aims to launch early next year and expects the treatment to be subject to an FDA risk evaluation and mitigation strategy, or REMS. He stressed that negative patient or provider experiences early on could damage the broader psychedelics field.
Nath cited Phase 3 data showing that roughly a quarter of patients had a clinically meaningful response after a single six-hour supervised session, rising to about 40% after a second dose three weeks later. He said responders may see benefits lasting up to a year after two or three administrations. But Steven Hyman, a Harvard professor and former director of the National Institute of Mental Health, cautioned that significant scientific questions remain. He noted that patients often know they have received a psychedelic, compromising trial blinding, and that it is unclear whether the psychedelic experience itself is necessary for the drugs to work.
Nath and Hyman diverged on psychotherapy: Compass deliberately separated psychotherapy from its trials, with Nath arguing the company's role is to develop a drug, not dictate psychological care. Hyman said psychotherapy could help patients process powerful emotions, but researchers have yet to determine how much benefit comes from the drug's pharmacology versus the experience itself. Both agreed on the need for rigor; Hyman compared the field's trajectory to cannabis and stressed long-term safety monitoring. He also noted that access and affordability remain major hurdles, with Compass still working on reimbursement for the required clinical monitoring.