Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced the presentation of Phase 1 data and plans for an adaptive Phase 2 field study of TNX-4800, a long-acting monoclonal antibody candidate for the prevention of Lyme disease. The company expects to initiate the Phase 2 study in the first half of 2027, pending agreement with the U.S. Food and Drug Administration (FDA).
TNX-4800 targets Borrelia burgdorferi, the bacterium that causes Lyme disease, and is designed to provide extended protection during tick season. The candidate is licensed from UMass Chan Medical School. Tonix highlights its potential advantages over traditional vaccine approaches, noting the absence of currently approved prophylactic options for Lyme disease in the United States.
Lyme disease is a growing public health concern, with an estimated 476,000 cases diagnosed and treated annually in the U.S., according to the Centers for Disease Control and Prevention. The need for effective prevention strategies is underscored by the limitations of existing methods, such as tick avoidance and early antibiotic treatment. TNX-4800 aims to fill this gap by offering a long-acting antibody that could provide immediate and sustained protection.
The Phase 1 data, presented at a recent medical conference, demonstrated that TNX-4800 was well-tolerated and showed pharmacokinetic profiles supporting a single-dose, season-long administration. These findings support the advancement to a Phase 2 field study, which will evaluate the efficacy of TNX-4800 in preventing Lyme disease in endemic areas.
Tonix Pharmaceuticals is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. The company’s CNS portfolio includes TONMYA (cyclobenzaprine HCl sublingual tablets 2.8mg), the first new treatment for fibromyalgia in more than 15 years, as well as acute migraine products Zembrace SymTouch and Tosymra. Tonix is also exploring TONMYA in Phase 2 trials for major depressive disorder and acute stress disorder.
In immunology, beyond TNX-4800, Tonix is advancing TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. These programs underscore the company’s commitment to addressing high unmet medical needs.
The full press release is available at https://ibn.fm/yB2M8. For more information on Tonix Pharmaceuticals, visit their newsroom at https://ibn.fm/TNXP.
