Tonix shares TNX-4800 Lyme disease prevention presentation

Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals Holding Corp.

TNXP

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  • Tonix published a research presentation on TNX-4800, a long-acting human monoclonal antibody being developed to prevent Lyme disease in the U.S.
  • Program targets Borrelia burgdorferi outer surface protein A; positioned as a subcutaneous two-dose seasonal regimen with a booster at about 12 weeks.
  • Phase 1 study (NCT04863287) completed; presentation cites favorable safety, tolerability, pharmacokinetics, immunogenicity, with measurable serum levels at 48 hours.
  • Company planning an adaptive Phase 2 field study to test prevention in volunteers from Lyme-endemic areas, pending FDA agreement.
  • Milestones include an FDA Type C meeting in early 3Q 2026; GMP manufacturing underway with Phase 2 initiation targeted for 1H 2027.


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