Compass Pathways Successfully Achieves Primary Endpoint in Second Phase 3 Trial Evaluating COMP360 Psilocybin for Treatment-Resistant Depression

Two highly statistically significant positive Phase 3 trials confirm highly differentiated profile for COMP360, demonstrating a level of clinical effect that has historically been extremely difficult to achieve in Treatment Resistant Depression (TRD)

Two independent Phase 3 trials (COMP005 and COMP006) evaluated COMP360 (synthetic psilocybin) in adults with treatment-resistant depression (TRD).

Both trials were randomised, double-blind, and compared active doses of COMP360 to a low-dose 1 mg control. The primary endpoint in both studies was the change in Montgomery Åsberg Depression Rating Scale (MADRS) score at Week 6.

Efficacy

• COMP005 (single 25 mg dose, n≈258):

  • Primary endpoint: MADRS change at Week 6 showed a mean difference of –3.6 points versus 1 mg control (p < 0.001).

  • Clinically meaningful reduction (≥25% decrease in MADRS): 25% of participants in the 25 mg arm.

  • Durability: Participants achieving a clinically meaningful reduction at Week 6 maintained this effect through Week 26 following one or two doses.

• COMP006 (two 25 mg doses, n≈581):

  • Primary endpoint: MADRS change at Week 6 showed a mean difference of –3.8 points versus 1 mg control (p < 0.001).

  • Clinically meaningful reduction (≥25% decrease in MADRS): 39% of participants in the 25 mg arm.

  • Time course: Statistical separation from control was observed from the day following administration and maintained through Week 6.

Safety

• Across both trials, COMP360 was generally well tolerated.

• No unexpected safety findings were reported.

• Serious adverse events (SAEs) were infrequent: 5% in COMP005 25 mg arm, 2% in COMP006 25 mg arm.

• Reported SAE suicidal ideation was <1% across both trials, with one occurrence in the 1 mg control arm.

Regulatory Status

• Compass Pathways has requested a meeting with the FDA to discuss a rolling New Drug Application (NDA) submission and expects to complete NDA filing in Q4.

Compass Pathways successfully achieves primary endpoint in second phase 3 trial evaluating COMP360 psilocybin for treatment-resistant depression. News release. Compass Pathways plc; February 17, 2026. Access here

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