Clinical TrialAug 12, 2026, 06:02 AM
Annexon Adds Month 24 Dual Primary Endpoint to ARCHER II Trial
AI Summary
Annexon, Inc. announced a significant update to its Phase 3 ARCHER II trial for vonaprument, adding a Month 24 dual primary endpoint to complement the existing Month 15 endpoint for dry age-related macular degeneration (AMD) with geographic atrophy (GA). This strategic move aims to maximize the drug's potential and evaluate its longer-term profile without altering study operations. The company also launched an open-label extension study to assess long-term safety and benefits. Month 15 data is expected in Q4 2026, with Month 24 data following in Q3 2027.
Key Highlights
- Added Month 24 dual primary endpoint to Phase 3 ARCHER II trial for vonaprument.
- Launched an open-label extension (OLE) study for long-term safety and benefit.
- Month 15 primary endpoint data expected in Q4 2026.
- Month 24 primary endpoint analysis expected in Q3 2027.
- ARCHER II sub-study results anticipated in Q1 2027.
- Vonaprument holds US FDA Fast Track and EMA PRIME designations.
Price Impact
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