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

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. 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. TNX-4800 targets Borrelia burgdorferi, the bacterium that causes Lyme disease, and is designed to provide extended protection during tick season, potentially offering advantages over traditional vaccine approaches.

According to the announcement, there are currently no approved prophylactic options for Lyme disease in the United States. The candidate was licensed from UMass Chan Medical School. 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 recently approved flagship medicine, TONMYA (cyclobenzaprine HCl sublingual tablets 2.8mg), is the first new treatment for fibromyalgia in more than 15 years.

The Phase 1 data for TNX-4800 were presented, though specific results were not detailed in the announcement. The planned adaptive Phase 2 field study will evaluate the monoclonal antibody's efficacy in preventing Lyme disease. Tonix's CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace SymTouch and Tosymra. The company is also advancing a pipeline of immunology programs, including TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection.

Tonix is maximizing the science behind TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder. Additionally, the CNS portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. The company noted that its product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

The implications of this announcement are significant given the burden of Lyme disease in the United States, where ticks are prevalent and existing prevention methods are limited. If successful, TNX-4800 could become the first prophylactic option for Lyme disease, offering a new tool to combat the growing incidence of tick-borne illnesses. The long-acting nature of the monoclonal antibody may provide sustained protection during peak tick season, potentially reducing the need for frequent dosing associated with vaccines.

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.