Tonix Pharmaceuticals Holding Corp. has provided program updates on TNX-4800, a long-acting human monoclonal antibody designed for seasonal prophylaxis against Lyme disease. The investigational product targets the outer surface protein A of Borrelia burgdorferi, the bacterium that causes Lyme disease, and is being developed as a once-yearly subcutaneous administration intended to provide protection throughout the U.S. tick season.
There are currently no FDA-approved vaccines or prophylactics for Lyme disease, creating a significant unmet medical need. The company 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, and expects to have GMP-manufactured investigational product available for testing in early 2027.
Tonix's infectious disease portfolio includes TNX-4800 as a Phase 2-ready long-acting humanized monoclonal antibody for the seasonal prevention of Lyme disease. The company also markets FDA-approved TONMYA, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, which is the first new prescription medicine approved by the FDA for fibromyalgia in more than 15 years. Additional marketed products include two treatments for acute migraine in adults: Zembrace SymTouch and Tosymra.
The company's development portfolio focuses on central nervous system disorders, immunology, immuno-oncology, rare disease and infectious disease. Tonix's immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a Phase 2-ready Fc-modified humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases.
Tonix's rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome and expected to start a potential pivotal Phase 2 study in 2026. The company's infectious disease portfolio also includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. Department of Defense's Defense Threat Reduction Agency for up to $34 million over five years.
For investors seeking additional information, the latest news and updates relating to Tonix Pharmaceuticals are available in the company's newsroom at https://ibn.fm/TNXP. The company's product development candidates are investigational new drugs or biologics whose efficacy and safety have not been established and have not been approved for any indication.
