Psilocybin therapy demonstrates sustained clinical benefit in treatment-resistant depression

New results from a trial investigating a synthetic form of psilocybin, administered with psychological support, showed that it extended the time participants with treatment-resistant depression (TRD) were free from depressive symptoms. A single 25mg dose of COMP360 psilocybin had benefit over smaller 1mg and 10mg doses in the 52-week COMP004 follow-up study to the Phase IIb (COMP001 and COMP003) trials. In the Phase IIb trial COMP001, a single 25mg dose of COMP360 psilocybin provided a “rapid and highly statistically significant reduction in depressive symptoms compared to COMP360 1mg dose after three weeks, with durable response for up to 12 weeks”, Compass Pathways highlighted.

Key findings from the COMP004 follow-up study investing psilocybin for TR-depression

The new data from this study was published in the Journal of Clinical Psychiatry.

Analysis of the COMP001 trial showed that the patients given 25mg experienced a longer time to relapse, compared with 10mg and 1mg.

Median time to a depressive event were as follows:
• Ninety-two days for the 25mg dose group
• In the 10mg group, 83 days
• Sixty-two days for the 1mg group.

Furthermore, a post hoc analysis showed a “substantial difference” in time to depressive event in COMP004 participants, compared to individuals in the COMP001 study. The differences were observed in the 25mg group when compared to the 10mg and 1mg groups.

Specifically, median times of 189 days were reported in the 25mg group. Then for participants in the 10mg group, the time to a depressive event was 43 days. This metric was 21 days for individuals in the 1mg group, Compass Pathways shared.

“This study together with the Phase IIb (COMP001) suggest the potential of COMP360 to provide rapid and durable clinical benefits from a single administration. We continue to explore the full profile of COMP360 in our ongoing Phase III clinical development programme and we look forward to seeing the first Phase III data from our COMP005 trial in the second quarter,” said Dr Guy Goodwin, Chief Medical Officer, Compass Pathways.

The COMP006 26-week data is anticipated in the second half of 2026, according to Compass Pathways.

COMP360 was found to be generally well tolerated by participants in the COMP004 study.