Tonix Pharmaceuticals Reports Phase 1 Data for Lyme Disease Prevention Antibody, Plans Phase 2 Study

Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) has announced the presentation of Phase 1 data and outlined plans for an adaptive Phase 2 field study of TNX-4800, a long-acting monoclonal antibody designed to prevent 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).

Lyme disease, caused by the bacterium Borrelia burgdorferi and transmitted through tick bites, is a growing public health concern in the United States, with an estimated 476,000 cases diagnosed annually, according to the Centers for Disease Control and Prevention. Currently, there are no approved prophylactic options available in the U.S., leaving individuals in endemic areas with limited prevention strategies beyond tick avoidance and prompt removal.

TNX-4800, licensed from UMass Chan Medical School, is a monoclonal antibody that targets Borrelia burgdorferi and is designed to provide extended protection throughout tick season. Tonix highlights its potential advantages over traditional vaccine approaches, including rapid onset of action and suitability for individuals with compromised immune systems. The Phase 1 data, presented at a recent medical conference, demonstrated a favorable safety profile and pharmacokinetics supporting a single-dose regimen for a full tick season.

The planned Phase 2 study will be an adaptive field trial designed to evaluate the efficacy of TNX-4800 in preventing Lyme disease in individuals living in or traveling to high-incidence areas. The adaptive design allows for modifications based on interim results, potentially accelerating the development timeline. Tonix noted that the initiation of the Phase 2 study is contingent on FDA agreement on the study design and endpoints.

This development is significant given the high unmet medical need for Lyme disease prevention. Traditional vaccines have faced challenges, including limited duration of protection and public hesitancy. Monoclonal antibodies offer an alternative approach that could provide immediate protection without requiring an individual’s immune system to generate a response. If successful, TNX-4800 could become the first prophylactic option for Lyme disease in the U.S.

Tonix Pharmaceuticals is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments. The company recently received FDA approval for TONMYA (cyclobenzaprine HCl sublingual tablets 2.8mg), the first new treatment for fibromyalgia in over 15 years. Tonix also markets acute migraine products Zembrace SymTouch and Tosymra. Beyond its commercial CNS infrastructure, the company is advancing a pipeline of immunology programs, including TNX-4800 for Lyme disease prophylaxis and TNX-1500, a third-generation CD40 ligand inhibitor for preventing kidney transplant rejection.

For more information on Tonix Pharmaceuticals and its pipeline, visit the company’s newsroom at https://ibn.fm/TNXP. The full press release on TNX-4800 is available at https://ibn.fm/yB2M8.

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