Tonix Pharmaceuticals Advances Lyme Disease Prevention with Phase 1 Data and Plans for Phase 2 Study

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 for the prevention of Lyme disease, with initiation expected in the first half of 2027 pending FDA agreement. The candidate, licensed from UMass Chan Medical School, targets Borrelia burgdorferi and is designed to provide extended protection during tick season, with the company highlighting its potential advantages over traditional vaccine approaches and noting the absence of currently approved prophylactic options in the United States.

Lyme disease affects hundreds of thousands of people annually in the U.S., and current prevention methods rely on tick avoidance and early treatment. TNX-4800 aims to fill this gap by offering a single-dose, long-lasting antibody that could protect individuals throughout tick season. The Phase 1 data, presented at a recent medical conference, demonstrated favorable safety and pharmacokinetics, supporting progression to field studies. The planned Phase 2 adaptive design will allow for efficient evaluation of efficacy in real-world settings, potentially accelerating development.

The importance of this announcement lies in the significant unmet medical need for Lyme disease prophylaxis. Unlike vaccines, which require the immune system to generate its own antibodies, monoclonal antibodies like TNX-4800 provide immediate protection. This could be particularly beneficial for individuals with compromised immune systems or those who do not respond well to vaccines. Additionally, the long-acting formulation may reduce the need for frequent dosing, improving compliance.

Tonix Pharmaceuticals is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments. The company's flagship medicine, TONMYA™ (cyclobenzaprine HCl sublingual tablets 2.8mg), is the first new treatment for fibromyalgia in more than 15 years. Tonix's CNS portfolio also includes products for acute migraine and pipeline candidates for major depressive disorder, acute stress disorder, and Prader-Willi syndrome. In immunology, TNX-4800 for Lyme disease and TNX-1500, a third-generation CD40 ligand inhibitor for prevention of kidney transplant rejection, are key pipeline assets.

For more information on Tonix Pharmaceuticals and its pipeline, visit the company's newsroom at https://ibn.fm/TNXP. The full press release is available at https://ibn.fm/yB2M8.