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FAQ: Tonix Pharmaceuticals' TNX-4800 Lyme Disease Prophylaxis Program Update
TL;DR
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.
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TNX-4800 is a long-acting human monoclonal antibody designed for seasonal prophylaxis against Lyme disease, targeting the outer surface protein A of Borrelia burgdorferi, the bacterium that causes Lyme disease.
TNX-4800 is being developed as a once-yearly subcutaneous administration intended to provide protection throughout the U.S. tick season.
This is significant because there are currently no FDA-approved vaccines or prophylactics for Lyme disease, making TNX-4800 a potential first-in-class preventive treatment.
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 markets FDA-approved TONMYA™ for fibromyalgia treatment, as well as Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray) for acute migraine treatment in adults.
Tonix has development programs focused on CNS disorders, immunology, immuno-oncology, rare disease and infectious disease, including TNX-1500 for organ transplant rejection and autoimmune diseases, TNX-2900 for Prader-Willi syndrome, TNX-801 for mpox and smallpox, and TNX-4200 for broad-spectrum antiviral applications.
All of Tonix's product development candidates are investigational new drugs or biologics whose efficacy and safety have not been established and have not been approved for any indication.
The latest news and updates relating to TNXP are available in the company's newsroom at https://ibn.fm/TNXP.
Tonix is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, and owns and operates a state-of-the-art infectious disease research facility in Frederick, Maryland.
Curated from InvestorBrandNetwork (IBN)
