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Tonix Advances Lyme Disease Prevention with Once-Yearly Antibody TNX-4800

Tonix Pharmaceuticals advances TNX-4800, a once-yearly antibody for Lyme disease prevention. No FDA-approved vaccines exist currently. Company plans FDA meeting in 2026 for Phase 2/3 development.

Lyme disease represents a growing public health concern, with approximately 476,000 Americans diagnosed and treated annually according to CDC estimates, and cases expanding geographically due to climate change and other factors. The absence of FDA-approved vaccines or prophylactics since the withdrawal of LYMErix in 2002 has left millions at risk, particularly in endemic regions where tick exposure is common during outdoor activities. TNX-4800's potential as a once-yearly preventive could transform Lyme disease management by offering protection throughout the entire tick season, reducing the burden of diagnosis, treatment complications like post-treatment Lyme disease syndrome, and healthcare costs. For individuals in high-risk areas, this development represents hope for safer engagement with nature without constant anxiety about tick-borne illness. From a broader perspective, successful development could establish a new paradigm for seasonal infectious disease prevention using long-acting monoclonal antibodies, potentially applicable to other vector-borne diseases.