Curated News
By: NewsRamp Editorial Staff
December 29, 2025
Tonix Advances Lyme Disease Prevention with Once-Yearly Antibody TNX-4800
TLDR
- Tonix Pharmaceuticals' TNX-4800 offers a potential first-mover advantage as the only FDA-approved seasonal prophylaxis for Lyme disease, targeting a large unmet market.
- TNX-4800 is a long-acting monoclonal antibody targeting Borrelia burgdorferi's outer surface protein A, administered once yearly subcutaneously to provide protection throughout tick season.
- This development could significantly reduce Lyme disease cases, improving public health and quality of life for millions at risk of this debilitating infection.
- Tonix plans to use a controlled human infection model in Phase 2/3 trials, an innovative approach to accelerate Lyme disease prevention development.
Impact - Why it Matters
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.
Summary
Tonix Pharmaceuticals (NASDAQ: TNXP), a fully-integrated biotechnology company, has announced significant program updates for TNX-4800, a long-acting human monoclonal antibody designed for seasonal prophylaxis against Lyme disease. This investigational biologic targets the outer surface protein A of Borrelia burgdorferi, the bacterium responsible for Lyme disease, and is being developed as a once-yearly subcutaneous administration intended to provide protection throughout the U.S. tick season. The company emphasized that there are currently no FDA-approved vaccines or prophylactics for Lyme disease, positioning TNX-4800 as a potential breakthrough in infectious disease prevention. Tonix plans to meet with the FDA in 2026 to discuss Phase 2/3 development options, including the potential use of a controlled human infection model, and expects to have GMP-manufactured investigational product available for testing in early 2027.
Tonix Pharmaceuticals Holding Corp. markets several FDA-approved products including TONMYA™, a first-in-class, non-opioid analgesic for fibromyalgia that represents the first new prescription medicine approved for this condition in over 15 years, as well as two treatments for acute migraine in adults: Zembrace® SymTouch® and Tosymra®. The company's diverse development portfolio spans central nervous system disorders, immunology, immuno-oncology, rare diseases, and infectious diseases. Key candidates include TNX-102 SL for acute stress reaction and major depressive disorder, TNX-1500 for preventing organ transplant rejection and treating autoimmune diseases, TNX-2900 for Prader-Willi syndrome, TNX-801 for mpox and smallpox, and TNX-4200, a broad-spectrum antiviral agent developed under a contract with the U.S. Department of Defense's Defense Threat Reduction Agency. The company operates a state-of-the-art infectious disease research facility in Frederick, Maryland, underscoring its commitment to advancing novel therapeutics.
For more detailed information, readers can view the full press release at https://ibn.fm/Wt9Ek. Additional updates relating to TNXP are available in the company's newsroom at https://ibn.fm/TNXP. This announcement was distributed through InvestorWire, a specialized communications platform within the Dynamic Brand Portfolio at IBN that provides advanced wire-grade press release syndication and comprehensive corporate communications solutions for private and public companies seeking to reach investors, journalists, and the general public. InvestorWire's services include article and editorial syndication to over 5,000 outlets, enhanced press release features, social media distribution through IBN's extensive network, and tailored corporate communications solutions designed to maximize brand awareness and market impact.
Source Statement
This curated news summary relied on content disributed by InvestorBrandNetwork (IBN). Read the original source here, Tonix Advances Lyme Disease Prevention with Once-Yearly Antibody TNX-4800
