From 6d4ad3213d30dd6c6da924f94638aef2f367bddf Mon Sep 17 00:00:00 2001 From: Teleo Agents Date: Mon, 11 May 2026 04:27:48 +0000 Subject: [PATCH] vida: extract claims from 2026-04-24-compass-pathways-fda-rolling-nda-priority-voucher-comp360 - Source: inbox/queue/2026-04-24-compass-pathways-fda-rolling-nda-priority-voucher-comp360.md - Domain: health - Claims: 0, Entities: 1 - Enrichments: 2 - Extracted by: pipeline ingest (OpenRouter anthropic/claude-sonnet-4.5) Pentagon-Agent: Vida --- ...hase3-trd-single-dose-26week-durability.md | 7 +++++ entities/health/comp006-trial.md | 28 +++++++++++++++++++ ...da-rolling-nda-priority-voucher-comp360.md | 5 +++- 3 files changed, 39 insertions(+), 1 deletion(-) create mode 100644 entities/health/comp006-trial.md rename inbox/{queue => archive/health}/2026-04-24-compass-pathways-fda-rolling-nda-priority-voucher-comp360.md (98%) diff --git a/domains/health/psilocybin-achieves-positive-phase3-trd-single-dose-26week-durability.md b/domains/health/psilocybin-achieves-positive-phase3-trd-single-dose-26week-durability.md index f17628a80..9bfa5bdd5 100644 --- a/domains/health/psilocybin-achieves-positive-phase3-trd-single-dose-26week-durability.md +++ b/domains/health/psilocybin-achieves-positive-phase3-trd-single-dose-26week-durability.md @@ -32,3 +32,10 @@ Oregon's real-world implementation shows facilitators specializing in trauma (83 **Source:** Bendable Therapy Oregon Measure 109 study, March 2024-April 2025 Oregon real-world naturalistic study shows large effect sizes at 30-day follow-up (PHQ-8: -4.63 points, d=0.90; GAD-7: -4.85 points, d=1.04; WHO-5: +10.67 points, d=2.14) with average dose 27.8mg TPE. However, follow-up limited to 30 days, preventing durability comparison with Compass Phase 3's 26-week endpoint. Study population differs from treatment-resistant depression trials: only 51.1% had depression diagnosis, 64.8% had prior psilocybin experience, and clients were self-selected paying customers rather than trial participants. + + +## Extending Evidence + +**Source:** Compass Pathways press release, April 24, 2026 + +COMP360 completed two consecutive positive Phase 3 trials (COMP005 n=258, COMP006 n=568), becoming the first psychedelic to achieve this milestone. COMP006 showed 39% response rate vs 23% control with rapid onset from next day, and 40%+ of non-remitters achieved remission after second dose. FDA granted rolling NDA review and Commissioner's National Priority Voucher, compressing review timeline to 1-2 months (vs standard 6-12 months). Rolling NDA completion expected Q4 2026, with potential FDA approval as early as Q4 2026-Q1 2027. diff --git a/entities/health/comp006-trial.md b/entities/health/comp006-trial.md new file mode 100644 index 000000000..4f8c1353f --- /dev/null +++ b/entities/health/comp006-trial.md @@ -0,0 +1,28 @@ +# COMP006 Trial + +**Type:** Phase 3 randomized controlled trial +**Sponsor:** Compass Pathways +**Intervention:** COMP360 (synthetic psilocybin) +**Indication:** Treatment-resistant depression (TRD) +**Status:** Completed (results announced February 2026) + +## Design +- **N = 568** participants +- **Arms:** 25mg vs 10mg vs 1mg (placebo-like control) +- **Dosing:** 2 doses administered 3 weeks apart +- **Primary endpoint:** MADRS change from baseline + +## Results +- **Primary endpoint met:** MADRS change -3.8 points vs control (p<0.001) +- **Response rate:** 39% vs 23% control at week 6 +- **Onset:** Rapid improvement from next day post-dose +- **Second dose benefit:** 40%+ of non-remitters after first dose achieved remission after second dose +- **Durability:** Part B 26-week durability data expected early Q3 2026 + +## Significance +COMP006 is the second consecutive positive Phase 3 trial for COMP360, making it the first psychedelic compound to achieve two positive Phase 3 results. Combined with COMP005, this formed the basis for FDA rolling NDA review and Commissioner's National Priority Voucher (April 2026). + +## Timeline +- **2026-02** — Results announced +- **2026-04-24** — FDA granted rolling NDA review based on COMP005 + COMP006 data +- **2026-Q3** — Part B 26-week durability data expected (final dataset for NDA) \ No newline at end of file diff --git a/inbox/queue/2026-04-24-compass-pathways-fda-rolling-nda-priority-voucher-comp360.md b/inbox/archive/health/2026-04-24-compass-pathways-fda-rolling-nda-priority-voucher-comp360.md similarity index 98% rename from inbox/queue/2026-04-24-compass-pathways-fda-rolling-nda-priority-voucher-comp360.md rename to inbox/archive/health/2026-04-24-compass-pathways-fda-rolling-nda-priority-voucher-comp360.md index 6cda11bce..4a19990f9 100644 --- a/inbox/queue/2026-04-24-compass-pathways-fda-rolling-nda-priority-voucher-comp360.md +++ b/inbox/archive/health/2026-04-24-compass-pathways-fda-rolling-nda-priority-voucher-comp360.md @@ -7,10 +7,13 @@ date: 2026-04-24 domain: health secondary_domains: [] format: press-release -status: unprocessed +status: processed +processed_by: vida +processed_date: 2026-05-11 priority: high tags: [psilocybin, Compass-Pathways, FDA, NDA, COMP360, TRD, regulatory, psychedelic, approval-timeline] intake_tier: research-task +extraction_model: "anthropic/claude-sonnet-4.5" --- ## Content