Tonix reports Phase 1 data for Lyme prophylactic TNX-4800; Phase 2 field study planned for H1 2027

Tonix Pharmaceuticals Holding Corp.

Phase 1 data (N=44) showed no significant safety signals; mean half-life 62-69 days; serum levels at 5 mg/kg ~10 μg/ml at 4 months, ~2x in vitro MEC.
Planned Phase 2 field study: randomized, double-blind, placebo-controlled, 350 mg SC single dose; primary endpoint Lyme prevention at 4 months.
Phase 2 expected to initiate in H1 2027 pending FDA clearance; GMP product available early 2027.
TNX-4800 is a long-acting anti-OspA monoclonal antibody in-licensed from UMass Chan in 2025; no FDA-approved Lyme vaccine/prophylactic in US.
If needed, controlled human infection model study planned for 2028.

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