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vida: extract claims from 2025-06-23-compass-pathways-comp005-psilocybin-phase3-trd

- 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>

2026-05-10 04:33:02 +00:00

2.2 KiB

Raw Blame History

Compass Pathways

Type: Clinical-stage biopharmaceutical company
Focus: Mental health, psychedelic therapeutics
Headquarters: United Kingdom
Lead Asset: COMP360 (synthetic psilocybin)

Overview

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.

Key Programs

COMP360 Psilocybin

Indication: Treatment-resistant depression (TRD)
Mechanism: 5-HT2A receptor agonism with embedded psychological support protocol
Status: Phase 3 (COMP005 positive, COMP006 pending)
Regulatory: FDA Breakthrough Therapy Designation, Commissioner National Priority Voucher (April 2026)

Clinical Evidence

COMP005 Phase 3 Trial

Design: Randomized, double-blind, placebo-controlled (n=258, 32 US sites)
Population: Treatment-resistant depression (≥2 failed antidepressant courses)
Intervention: Single dose COMP360 25mg vs. placebo with psychological support protocol
Primary Endpoint: MADRS change at Week 6: -3.6 points (95% CI [-5.7, -1.5], p<0.001)
Durability: Benefits maintained through 26-week follow-up from single dose
Safety: All adverse events mild-to-moderate, resolved within 24 hours

Regulatory Pathway

NDA Filing: Expected Q4 2026 (pending COMP006 26-week data)
Breakthrough Designation: Held for multiple years
Priority Voucher: Received April 24, 2026

Significance

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.

Timeline

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
2026-04-24 — Receives Commissioner National Priority Voucher
2026-Q4 — NDA filing expected (pending COMP006 data)

2.2 KiB Raw Blame History