1. Tonix plans Phase 2/3 trial for TNX-4800 in Lyme disease by 2026. 2. TNX-4800 offers a seasonal single-dose prophylaxis against Lyme disease. 3. Approximately 70 million in endemic U.S. areas may benefit from TNX-4800. 4. TNX-4800 demonstrated 95% efficacy in preventing infection in primate studies. 5. Tonix aims for FDA Biologics Licensing Application for TNX-4800 by 2027.
FAQ
Why Bullish?
The projected clinical development of TNX-4800 and large potential market can significantly enhance TNXP's stock performance as seen with other biotech successes upon advancement in clinical trials.
How important is it?
The article discusses clinical advancements and market potential for TNX-4800, crucial elements that can drive investor interest and stock performance.
Why Long Term?
The long-term view is supported by the expected FDA approval and significant market need for Lyme disease prophylaxis, similar to past biotech successes like Gilead's Hepatitis C treatments.
Tonix Pharmaceuticals Advances Lyme Disease Prophylaxis with TNX-4800
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) has announced critical program updates regarding TNX-4800, a novel long-acting monoclonal antibody (mAb) designed for the seasonal prevention of Lyme disease. This announcement, made on December 29, 2025, outlines the company's plans to initiate clinical trials for TNX-4800 in early 2027, aiming to offer a protective solution to approximately 70 million people living in Lyme disease-endemic areas across the United States.
Clinical Development Plans for TNX-4800
Tonix is currently exploring various clinical development pathways, including a controlled human infection model (CHIM) and an adaptive Phase 2/3 field study. Seth Lederman, M.D., CEO of Tonix Pharmaceuticals, stated, “We plan to meet with the FDA in 2026 to explore Phase 2/3 development options.” The goal is to demonstrate the efficacy of TNX-4800 using Borrelia-infected ticks in a manner that mimics natural infection.
Currently, there are no FDA-approved vaccines for Lyme disease, making TNX-4800 a promising candidate
What is TNX-4800?
TNX-4800, formerly known as mAb 2217LS, is engineered to target the outer surface protein A (OspA) of the Borrelia burgdorferi bacterium. This monoclonal antibody can provide near-immediate immunity after a single springtime administration, thus protecting individuals throughout the tick season. Unlike existing vaccines that depend on the body’s immune response, TNX-4800 offers direct immunity.
In preclinical studies involving non-human primates, TNX-4800 demonstrated a remarkable 95% efficacy in preventing Lyme infection after exposure to ticks. The antibody's formulation allows it to remain effective without multiple doses, avoiding the potential complications associated with traditional vaccines.
Pharmacokinetics and Safety Profile
The safety, tolerability, and pharmacokinetics of TNX-4800 were evaluated in a randomized, double-blind, sequential dose-escalation study (NCT04863287). In this study, 44 subjects received varying doses of TNX-4800, yielding the following insights:
- Drug exposure increased approximately 25 times with a 20 times increase in dosage.
- Serum TNX-4800 was detectable as early as 24 hours post-administration.
- Concentrations remained quantifiable for over 200 days in most participants, with some lasting up to 350 days.
- Anti-drug antibodies were observed in less than 10% of subjects, with no adverse effects on pharmacokinetics.
Generally, TNX-4800 was found to be safe and well-tolerated, with most adverse events being mild or moderate.
The Increasing Threat of Lyme Disease
Lyme disease, caused by Borrelia burgdorferi, is the most common vector-borne infection in the United States and is on the rise annually. It primarily affects individuals in the Northeast, mid-Atlantic, and upper Midwest regions, transmitting through infected Ixodes ticks. Symptoms include fever, headache, and fatigue, and if untreated, the disease can lead to severe complications affecting joints, the heart, and the nervous system.
Current treatment, while effective in many cases, is often delayed, with up to 20% of patients potentially developing Post-Treatment Lyme Disease Syndrome (PTLDS).
Tonix Pharmaceuticals' Commitment
Tonix Pharmaceuticals is a fully-integrated biotechnology firm focused on developing innovative therapeutics. In addition to TNX-4800, the company markets TONMYA™, an FDA-approved treatment for fibromyalgia, showcasing its commitment to addressing significant medical needs through advanced biotechnology.