Tonix Pharmaceuticals Unveils Phase 2/3-Ready Monoclonal Antibody for Lyme Disease Prevention

Reuters2025-12-29

Tonix Pharmaceuticals Unveils Phase 2/3-Ready Monoclonal Antibody for Lyme Disease Prevention

Tonix Pharmaceuticals Holding Corp. announced updates on the development of TNX-4800, a long-acting monoclonal antibody designed for the seasonal prevention of Lyme disease. The company plans to meet with the FDA in 2026 to discuss Phase 2/3 clinical development options, including the use of a controlled human infection model $(CHIM)$ that mimics natural infection with Borrelia-infected ticks. Tonix expects to have the investigational product available for clinical trials in early 2027. TNX-4800 is intended to provide near-immediate immunity after a single administration and could serve as an annual prophylactic treatment for people at risk of Lyme disease. The results have not yet been presented; the company is currently outlining its future clinical development plans.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Tonix Pharmaceuticals Holding Corp. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001999371-25-021194), on December 29, 2025, and is solely responsible for the information contained therein.

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