Tonix highlights pathway for potential single-dose, seasonal protection against Lyme Disease

Описание: Tonix Pharmaceuticals Holdings CEO Dr. Seth Lederman joined Steve Darling from Proactive to share an update on the company’s TNX-4800 program, underscoring its potential to address a significant unmet need in the prevention of Lyme disease. TNX-4800 is a long-acting human monoclonal antibody designed to target outer surface protein A of Borrelia burgdorferi, the bacterium responsible for causing Lyme disease in humans.

Lederman explained that TNX-4800 is being developed as a seasonal, once-yearly preventive treatment. The program envisions a single subcutaneous injection administered in the spring, providing protection through the fall and covering the entire tick season in the United States. He noted that there are currently no FDA-approved vaccines or prophylactic therapies available in the U.S. to prevent Lyme disease, highlighting the importance of developing new preventive options.

According to the company, TNX-4800 is designed to deliver near-immediate immunity following a single administration, which differentiates it from Lyme disease vaccine candidates currently in development that typically require multiple doses over time to achieve protective immunity. Tonix believes this rapid-onset protection could make TNX-4800 a convenient and effective solution for individuals living in or traveling to regions where Lyme disease is prevalent.

Tonix plans to advance the program toward the production of investigational product manufactured under Good Manufacturing Practices and plans to meet with the FDA in 2026 to propose a CHIM (controlled human infection model) study. This would involve volunteers receiving TNX-4800 or a control, then being exposed to Lyme-infected ticks in a controlled environment to test efficacy.Pending approval, the company aims to accelerate development and move toward broader field trials.

Lyme disease remains the most common vector-borne infection in the United States, with reported cases increasing each year. The disease is most prevalent in the Northeast, mid-Atlantic, and upper Midwest regions and is transmitted through the bite of infected Ixodes ticks. Early symptoms often include fever, headache, fatigue, and the characteristic erythema migrans rash. If left untreated, the infection can progress and spread to the joints, heart, and nervous system, potentially resulting in serious and long-term health complications.

Lederman said Tonix believes TNX-4800 has the potential to significantly reduce the burden of Lyme disease by offering a differentiated, single-dose, seasonal preventive approach in a market with limited existing options.

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