Compass Pathways' Psychedelic Trials: A Milestone Moment for the Sector

Compass Pathways is conducting Phase 3 trials for synthetic psilocybin COMP360, with the potential to offer transformational properties for patients with serious mental illness. The company is focusing on equitable delivery strategies and has formed a strategic collaboration with HealthPort to inform the delivery of COMP360 in underserved communities. Data readouts from the current studies will be significant milestones for Compass, but Nath also sees the results in the context of the wider push to earn support for psychedelic treatments.

Compass Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation, has announced significant progress in its clinical trials for synthetic psilocybin COMP360. The company is preparing for Phase 3 trials, with a focus on equitable delivery strategies and strategic collaborations to ensure the treatment reaches underserved communities.

The latest study, an open-label trial involving 19 patients, demonstrated that COMP360 psilocybin therapy administered alongside SSRI antidepressants resulted in comparable treatment outcomes to those seen in COMPASS's Phase 2b trial, where patients had to taper off their SSRIs [1]. This finding challenges the widely-held belief that SSRI medication could interfere with psilocybin’s therapeutic effect and suggests that COMP360 could be an effective adjunctive therapy.

The study included 19 patients from clinical sites in Ireland and the United States, with the majority being female (68.4%) and an average age of 42 years. The primary endpoint was the change in baseline MADRS1 total score at 3 weeks, with 8 out of 19 patients (42.1%) being responders at week 3. The mean reduction from baseline in MADRS total score was 14.9 at week 3, indicating a rapid response from day 2 to week 3 after COMP360 therapy [1].

Compass Pathways is now preparing for a meeting with the FDA in early 2022 to finalize the design of its Phase 3 programme, which it expects to commence in Q3 2022 [1]. The company is also focusing on strategic collaborations to inform the delivery of COMP360 in underserved communities. For instance, a recent collaboration with HealthPort aims to ensure equitable access to COMP360 therapy [1].

The results of the current studies are significant milestones for Compass, but they also reflect the broader push to gain support for psychedelic treatments. The company's vision is to improve the lives of those suffering from mental health challenges who are not helped by current treatments.

References
1. [1] https://psychedelicalpha.com/news/compass-pathways-announces-positive-outcome-of-25mg-comp360-psilocybin-therapy-as-adjunct-to-ssri-antidepressants-in-open-label-treatment-resistant-depression-study