Compass Postpones Key Psilocybin Trial Results, Cuts 30% of Workforce

Compass Pathways, a developer in the psychedelic treatment field, has announced delays in its Phase III trials for a psilocybin-based therapy aimed at addressing treatment-resistant depression. This delay will impact the release of pivotal data and result in significant layoffs within the company.

Initially, Compass Pathways had planned to release data from its first Phase III trial, COMP005, by the current quarter, but this has now been postponed to the second quarter of 2025. Furthermore, data from the second Phase III trial, COMP006, which was expected around mid-2025, will now be delayed until the second half of 2026. This information was revealed during the company's third-quarter business update.

One of the main reasons for delaying the COMP006 trial, which involves a two-dose study, is due to increased regulatory scrutiny on functional unblinding. Functional unblinding poses a challenge as it could potentially allow trial participants to determine whether they have been administered the actual drug or a placebo. The decision follows the FDA's rejection of Lykos Therapeutics’ MDMA-assisted post-traumatic stress disorder therapy in August 2024, after an advisory committee highlighted concerns about functional unblinding.

To mitigate the risk of unblinding in their trials, Compass Pathways has decided to delay the data release for COMP006 until the 26-week mark, after the blinded portion of the trial is completed for all participants. During an earnings call, CEO Kabir Nath emphasized that it would be challenging for participants, who are mostly inexperienced with psychedelics, to ascertain which dose they received.

Additionally, Nath pointed out other complexities that contributed to the decision to delay the readouts. The use of multiple doses in the Phase III trial has increased logistical challenges for sites in scheduling patients and therapists, as well as for the patients themselves.

As a consequence of these delays, Compass Pathways will be reducing its workforce by about 30%, including some management positions. The company had 32 employees at the end of December 2023, with 19 of them primarily involved in research and development and clinical activities.

Nath stated that ensuring the success of their lead COMP360 program remains their top priority. He mentioned that the shift in the Phase III program timeline necessitated a thorough review of their operations to ensure that all resources are focused on this goal.

COMP360 has demonstrated promising results in earlier clinical studies. Data from the company's Phase IIb trial, which were published in the New England Journal of Medicine in November 2022, showed a significant reduction in depressive symptoms three weeks after a single dose of COMP360 in conjunction with psychological support. The response was observed to last up to 12 weeks after treatment.

In summary, Compass Pathways has adjusted the timelines for its pivotal Phase III trials of psilocybin for treatment-resistant depression, pushing the readouts to 2025 and 2026. This decision, driven by regulatory concerns and trial complexities, will also lead to a significant reduction in the company's workforce. Despite these delays, the company remains committed to the success of its COMP360 program, which has shown promising results in earlier trials.