Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) has provided program updates on TNX-4800, a long-acting human monoclonal antibody designed for seasonal prophylaxis against Lyme disease. The antibody targets the outer surface protein A of Borrelia burgdorferi, the bacterium that causes Lyme disease. Tonix is developing TNX-4800 as a once-yearly subcutaneous administration intended to provide protection throughout the U.S. tick season. The company emphasized that there are currently no FDA-approved vaccines or prophylactics for Lyme disease, underscoring the potential significance of this candidate.
Tonix plans to meet with the FDA in 2026 to discuss Phase 2/3 development options, including the potential use of a controlled human infection model. The company expects to have GMP-manufactured investigational product available for testing in early 2027. This timeline indicates a strategic approach to advancing the program through regulatory guidance and manufacturing readiness.
Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. The company markets FDA-approved TONMYA(TM), a first-in-class non-opioid analgesic for fibromyalgia, and two treatments for acute migraine: Zembrace(R) SymTouch(R) and Tosymra(R). Its development portfolio focuses on central nervous system disorders, immunology, immuno-oncology, rare disease, and infectious disease. Other infectious disease candidates include TNX-801 (vaccine for mpox and smallpox) and TNX-4200, a broad-spectrum antiviral agent under a contract with the U.S. Department of Defense’s Defense Threat Reduction Agency.
The TNX-4800 program addresses a significant unmet medical need. Lyme disease is the most common vector-borne disease in the United States, with hundreds of thousands of cases reported annually. Current prevention relies on tick avoidance and early antibiotic treatment, but no approved prophylactic exists. If successful, TNX-4800 could offer a convenient, once-yearly injection to protect individuals during tick season, potentially reducing the burden of Lyme disease.
Investors and stakeholders can view the full press release at https://ibn.fm/Wt9Ek. For more information about Tonix Pharmaceuticals, visit their newsroom at https://ibn.fm/TNXP.
