Clinical TrialAug 3, 2026, 07:11 AM
Tonix Aligns with FDA on Phase 2 Lyme Disease Study Design for TNX-4800
AI Summary
Tonix Pharmaceuticals announced receipt of official minutes from a Type C meeting with the FDA, confirming alignment on the design for an adaptive Phase 2 field study of TNX-4800 for seasonal prevention of Lyme disease. The study will enroll approximately 3,300 adult participants over two seasons, with a primary efficacy endpoint of Lyme disease prevention at six months after the first dose. Manufacturing of the investigational product is on track for delivery to study sites in Q1 2027, with the study planned to start in Q1 2027.
Key Highlights
- FDA aligned with Tonix on adaptive Phase 2 field study design for TNX-4800.
- Study to enroll 3,300 adult participants from Lyme-endemic areas over two seasons.
- Primary efficacy endpoint: Lyme disease prevention at six months after first dose.
- Key secondary efficacy endpoint: Lyme disease prevention at three months.
- Primary safety objective: Evaluate safety and tolerability over 52 weeks.
- Participants randomized 1:1 to TNX-4800 450 mg SC or placebo in a two-dose regimen.
- Investigational product manufacturing on track for Q1 2027 delivery to study sites.
- Planned start of the Phase 2 study in the first quarter of 2027.
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