Compass Pathways Announces Phase III Study for COMP360 in Treatment-Resistant Depression

Compass Pathways' Phase III study on COMP360 is evaluating the efficacy and safety of a psilocybin-based treatment for treatment-resistant depression. The study aims to assess the impact of a single 25 mg dose of COMP360 with psychological support on TRD symptoms. The study began in January 2023 and is ongoing, with the primary completion date yet to be announced. Positive results could enhance Compass Pathways' market position and impact competitors in the mental health treatment sector.

Compass Pathways plc (Nasdaq: CMPS), a biotechnology company focused on accelerating patient access to evidence-based mental health treatments, has reported positive results from its Phase III study on COMP360, an investigational synthetic psilocybin treatment for treatment-resistant depression (TRD). The study, which began in January 2023, demonstrated a highly statistically significant and clinically meaningful reduction in symptom severity at six weeks following a single 25 mg dose of COMP360 with psychological support [1].

The results of the first COMP360 Phase 3 trial (COMP005) showed a significant reduction in depression symptoms, indicating that COMP360 could be a paradigm-changing treatment option for individuals with TRD. The study also found no unexpected safety findings and no clinically meaningful imbalance in suicidal ideation [1]. The second ongoing pivotal Phase 3 trial (COMP006) continues to enroll participants and is expected to provide 26-week data in the second half of 2026 [1].

Compass Pathways is exploring options for a potential accelerated filing for COMP360 for TRD, given the promising results from the Phase III studies. The company has a cash position of $221.9 million as of June 30, 2025, with a cash runway into 2027 [1]. The management team will host a conference call on July 31, 2025, at 8:00 am ET (1:00 pm UK) to discuss these results and provide further updates [1].

The positive Phase III results for COMP360 could enhance Compass Pathways' market position and impact competitors in the mental health treatment sector. The company's focus on developing evidence-based treatments for serious mental health conditions aligns with its mission to find better ways to help and empower people with mental health conditions who are not helped by existing treatments [1].

References:
[1] https://ir.compasspathways.com/News--Events-/news/news-details/2025/Compass-Pathways-Announces-Second-Quarter-2025-Financial-Results-and-Business-Highlights/default.aspx