COMPASS Pathways (CMPS) Study update summary

Unmet need and study background

• Treatment-resistant depression (TRD) affects over 4 million U.S. adults annually, with high patient burden, chronicity, and increased risk of suicide and economic impact.

• Only two medicines are approved for TRD, with limited use, highlighting a significant unmet need.

Study design and participant characteristics

• Two pivotal Phase 3 trials (COMP005 and COMP006) evaluated COMP360 in TRD, enrolling over 1,000 participants with rigorous criteria for prior treatment failure and symptom severity.

• COMP005 used a single 25 mg dose vs placebo; COMP006 used two fixed 25 mg doses vs 10 mg and 1 mg, with three study parts up to 52 weeks.

• Baseline demographics and depression history were consistent with known TRD epidemiology.

Key study results and clinical insights

• Both Phase 3 trials met primary endpoints, showing highly statistically significant and clinically meaningful reductions in MADRS scores at Week 6 for COMP360 25 mg versus control arms.

• Rapid onset of action was observed from the day after dosing, with durable effects lasting up to 26 weeks for responders.

• In COMP005, 25% achieved a clinically meaningful MADRS reduction at Week 6, sustained through 26 weeks; in COMP006, this figure was 39% with two fixed doses.

• Over 40% of COMP005 partial responders remitted after a second dose.

• COMP360 is the first classic psychedelic to consistently achieve such results in TRD, with a highly differentiated efficacy profile compared to existing options.