Compass Pathways has announced a delay in the pivotal Phase III trial readouts for its psilocybin-based therapy, COMP360, intended for treatment-resistant depression (TRD). This decision, revealed in the company's third-quarter business update, will also result in a workforce reduction of approximately 30%.
The company initially anticipated data from the first Phase III trial, COMP005, this quarter. However, the timeline has been shifted to the second quarter of 2025. Furthermore, data from the second Phase III trial, COMP006, initially expected around mid-2025, is now projected for release in the second half of 2026.
Regulatory Scrutiny and Trial Design
The delay in COMP006, a two-dose study, is primarily attributed to heightened regulatory scrutiny regarding functional unblinding. This concern was underscored by the FDA's recent rejection of Lykos Therapeutics’ MDMA-assisted therapy for post-traumatic stress disorder (PTSD), following a negative advisory committee vote citing concerns that participants could discern whether they received the drug or a placebo.
To mitigate the risk of unblinding, Compass Pathways has decided to postpone the COMP006 data release until after the 26-week mark, ensuring the blinded portion of the trial is complete for all participants. CEO Kabir Nath stated that it would be difficult for the largely psychedelic-naive participants to determine their received dose.
Operational Adjustments
Nath also cited logistical complexities associated with multiple doses in the Phase III trial, impacting scheduling for patients and therapists, as contributing to the delay. In response to these changes, Compass Pathways will reduce its workforce by approximately 30%, including some management positions.
"Ensuring the success of our lead COMP360 program is our absolute priority," Nath stated. "The shift in the phase 3 pivotal program timeline has forced us to look carefully at our operations and ensure that every resource is focused on this goal."
COMP360 Background and Prior Results
COMP360 has demonstrated promise in earlier clinical studies. Phase IIb trial results, published in the New England Journal of Medicine in November 2022, showed a statistically significant reduction in depressive symptoms after three weeks following a single dose of COMP360 combined with psychological support. The response lasted up to 12 weeks.
