Tonix Pharmaceuticals (NASDAQ:TNXP) said it is advancing development plans for TNX-4800, a long-acting human monoclonal antibody designed for the prevention of seasonal Lyme disease, as the company prepares for regulatory discussions on potential late-stage clinical pathways.
The company said it plans to hold a meeting with the U.S. Food and Drug Administration in 2026 to explore Phase 2/3 development options.
These include the possible use of a controlled human infection model, or CHIM, as well as an adaptive Phase 2/3 field study design.
Tonix said it expects good manufacturing practice-grade investigational product for TNX-4800 to be available for clinical testing in early 2027.
The antibody targets outer surface protein A (OspA), a key antigen expressed by Borrelia burgdorferi, the bacterium responsible for Lyme disease.
The company estimates that roughly 70 million people in Lyme-endemic areas of the United States could potentially benefit from seasonal prophylaxis.
Tonix noted that there are currently no FDA-approved vaccines or preventive treatments on the market for Lyme disease.
According to the company, TNX-4800 is designed to provide near-immediate immunity following a single subcutaneous dose, offering seasonal protection during periods of high tick exposure.