Psychedelics Inching Forward – Psilocybin Therapy Shows Sustained Benefits for Treatment-Resistant Depression

Compass Pathways plc (Nasdaq: CMPS) has released new findings demonstrating the sustained antidepressant effects of its investigational psilocybin therapy, COMP360, for treatment-resistant depression. Published in the Journal of Clinical Psychiatry, the 52-week COMP004 follow-up study found that a single 25mg dose of COMP360 significantly prolonged the time patients remained free from depressive symptoms compared to lower doses. These results suggest that COMP360 could be a promising treatment for people who haven’t had success with traditional therapies, inferring progress in the therapeutic landscape of psychedelic drugs.

Key Findings Highlight Long-Term Efficacy of COMP360 Psilocybin Treatment: Extended Antidepressant Effects Observed

New data from the COMP004 (NCT04519957) follow-up study reinforces the potential of COMP360, a synthetic form of psilocybin, in treating patients with treatment-resistant depression (TRD). Administered with psychological support, a single 25mg dose demonstrated sustained antidepressant effects over a 52-week period, significantly outperforming lower doses. 

Building on the results of the Phase IIb trials (COMP001 and COMP003), which initially demonstrated the rapid and significant effects of a single 25 mg dose of COMP360, the findings of COMP004 further support its long-term potential. A single 25 mg dose of psilocybin showed a longer-lasting antidepressant effect over 52 weeks compared to the 1 mg and 10 mg doses. In the COMP001 trial, participants who received the higher dose saw a notable reduction in depressive symptoms within three weeks, with sustained benefits lasting up to 12 weeks. The follow-up study, COMP004, confirmed that individuals who received the 25 mg dose experienced significantly longer-lasting relief from depressive symptoms than those given the 10 mg or 1 mg doses.

Comparative Outcomes in Treatment-Resistant Depression

Analysis of the COMP001 trial indicated that patients who received 25mg of COMP360 had a longer time to relapse than those on lower doses. The median time to a depressive event was recorded as follows:

• 92 days for the 25mg dose group
• 83 days for the 10mg dose group
• 62 days for the 1mg dose group

Additionally, a post hoc analysis of the COMP004 trial demonstrated an even greater difference in the duration of antidepressant effects for participants transitioning from COMP001. Among those in the 25mg group, the median time to a depressive event extended to 189 days, compared to 43 days for the 10mg group and 21 days for the 1mg group. This suggests that COMP360’s benefits may persist even longer under certain conditions.

Addressing a Critical Unmet Need in Mental Health with Good Safety and Tolerability

The Road Ahead: Phase III Trials and Future Prospects

Compass Pathways is actively advancing the clinical development of COMP360. The COMP005 Phase III trial (NCT05624268), the largest randomized, controlled, double-blind psilocybin treatment study conducted to date, is set to deliver key findings soon. The top-line 6-week primary endpoint data is expected in the second quarter of 2025, while 26-week follow-up data from COMP006 will be available in the second half of 2026. These results will be pivotal in determining COMP360’s long-term efficacy and potential regulatory approval.

Dr. Guy Goodwin, Chief Medical Officer at Compass Pathways, emphasized the significance of these findings: “This study, together with the Phase IIb (COMP001), suggests 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 program and look forward to seeing the first Phase III data from our COMP005 trial in the second quarter.”

A Potential Paradigm Shift in Depression Treatment

The latest findings from COMP004 reinforce COMP360 psilocybin’s potential as a breakthrough treatment for TRD. With its ability to provide rapid, sustained relief from depressive symptoms, this investigational therapy offers hope to millions of individuals who struggle with conventional treatments. As Compass Pathways moves forward with Phase III trials, the industry eagerly anticipates further data that could pave the way for psilocybin-assisted therapy’s regulatory approval and broader clinical adoption.

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Author

Bernice Lottering