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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>
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44 lines
No EOL
2.2 KiB
Markdown
# Compass Pathways
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**Type:** Clinical-stage biopharmaceutical company
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**Focus:** Mental health, psychedelic therapeutics
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**Headquarters:** United Kingdom
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**Lead Asset:** COMP360 (synthetic psilocybin)
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## Overview
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Compass Pathways is a clinical-stage biopharmaceutical company developing COMP360, a proprietary synthetic psilocybin formulation for treatment-resistant depression and other mental health conditions. The company holds FDA Breakthrough Therapy Designation and reported the first positive Phase 3 efficacy data for any investigational psychedelic in June 2025.
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## Key Programs
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### COMP360 Psilocybin
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- **Indication:** Treatment-resistant depression (TRD)
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- **Mechanism:** 5-HT2A receptor agonism with embedded psychological support protocol
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- **Status:** Phase 3 (COMP005 positive, COMP006 pending)
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- **Regulatory:** FDA Breakthrough Therapy Designation, Commissioner National Priority Voucher (April 2026)
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## Clinical Evidence
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### COMP005 Phase 3 Trial
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- **Design:** Randomized, double-blind, placebo-controlled (n=258, 32 US sites)
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- **Population:** Treatment-resistant depression (≥2 failed antidepressant courses)
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- **Intervention:** Single dose COMP360 25mg vs. placebo with psychological support protocol
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- **Primary Endpoint:** MADRS change at Week 6: -3.6 points (95% CI [-5.7, -1.5], p<0.001)
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- **Durability:** Benefits maintained through 26-week follow-up from single dose
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- **Safety:** All adverse events mild-to-moderate, resolved within 24 hours
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## Regulatory Pathway
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- **NDA Filing:** Expected Q4 2026 (pending COMP006 26-week data)
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- **Breakthrough Designation:** Held for multiple years
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- **Priority Voucher:** Received April 24, 2026
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## Significance
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COMP005 represents the first Phase 3 evidence for a psychedelic drug and the first classic psychedelic to reach Phase 3 efficacy threshold, establishing proof-of-concept for FDA approval of the broader class.
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## Timeline
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- **2025-06-23** — COMP005 Phase 3 trial achieves primary endpoint with MADRS -3.6 point improvement (p<0.001), marking first positive Phase 3 data for any investigational psychedelic
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- **2026-04-24** — Receives Commissioner National Priority Voucher
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- **2026-Q4** — NDA filing expected (pending COMP006 data) |