Tonix announces TNX-4800 Phase 1 data, plans 2026 FDA meeting for Phase 2/3 Lyme disease prevention

Tonix Pharmaceuticals Holding Corp.

Phase 1 study of TNX-4800 in 44 subjects showed mean half-life of 62-69 days; detectable up to 12 months.
Company will meet with FDA in 2026 to explore Phase 2/3 development options including a controlled human infection model (CHIM).
Expects GMP investigational product available for clinical testing in early 2027.
TNX-4800 targets OspA of Borrelia burgdorferi; designed as annual seasonal prophylaxis for Lyme disease.
Anti-drug antibodies in <10% of subjects with no impact on PK; most adverse events mild or moderate.

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