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- Source: inbox/queue/2025-06-23-compass-pathways-comp005-psilocybin-phase3-trd.md - Domain: health - Claims: 2, Entities: 2 - Enrichments: 2 - Extracted by: pipeline ingest (OpenRouter anthropic/claude-sonnet-4.5) Pentagon-Agent: Vida <PIPELINE>
54 lines
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2.1 KiB
Markdown
54 lines
No EOL
2.1 KiB
Markdown
# COMP005 Phase 3 Trial
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**Sponsor:** Compass Pathways
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**Intervention:** COMP360 psilocybin 25mg single dose
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**Indication:** Treatment-resistant depression
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**Status:** Completed, positive primary endpoint
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**Reported:** June 23, 2025
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## Trial Design
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- **Phase:** 3
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- **Design:** Randomized, double-blind, placebo-controlled
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- **Sample Size:** n=258
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- **Sites:** 32 sites in the United States
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- **Population:** Treatment-resistant depression (≥2 failed antidepressant courses)
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- **Intervention:** Single dose COMP360 25mg vs. placebo
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- **Protocol:** Embedded psychological support (preparation, monitored session, integration)
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## Primary Endpoint
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**MADRS change from baseline at Week 6:**
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- Treatment difference: **-3.6 points** (95% CI [-5.7, -1.5])
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- **p<0.001** (highly statistically significant)
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## Secondary Outcomes
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- **Response Rate:** 25% achieved clinically meaningful MADRS reduction (≥25%) at week 6
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- **Durability:** Improvement maintained through 26-week follow-up after single dose
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- **Rapid Onset:** Statistically significant benefit from next day after dosing
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## Safety Profile
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- All treatment-emergent adverse events: mild or moderate severity
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- Most adverse events resolved within 24 hours
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- Frequently reported: headache, nausea, anxiety, visual hallucination
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- No clinically meaningful imbalance in suicidal ideation between arms
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- No unexpected safety findings
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## Historical Significance
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- **First investigational psychedelic to report positive Phase 3 efficacy data**
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- First classic psychedelic to reach Phase 3 evidence level
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- Establishes proof-of-concept for FDA approval pathway for psychedelic therapeutics
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## Clinical Context
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- Effect size (-3.6 MADRS points) comparable to existing TRD augmentation strategies (2-4 points)
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- Single-dose 26-week durability represents paradigm shift from daily-dosing chronic treatment model
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- Psychological support protocol is mandatory component, not optional adjunct
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- Treatment-resistant depression population: ~7M Americans who have failed 2+ antidepressant courses
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## Timeline
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- **2025-06-23** — Primary endpoint results announced: MADRS -3.6 (p<0.001), first positive Phase 3 data for any psychedelic |