Tonix Pharmaceuticals announced plans to explore clinical development options for TNX-4800, a long-acting human monoclonal antibody for Lyme disease. The investigational product is expected to be available for clinical trials in early 2027. Approximately 70 million individuals in Lyme disease endemic areas could benefit from pre-exposure prophylaxis. TNX-4800 offers near-immediate immunity against the bacteria causing Lyme disease. The company is considering a controlled human infection model study and a Phase 2/3 adaptive field study. TNX-4800’s unique prophylactic approach could revolutionize Lyme disease prevention.
TNX-4800 is a monoclonal antibody targeting Borrelia bacteria’s outer surface protein A. Studies in non-human primates showed 95% efficacy in preventing infection after tick exposure. The antibody has a long half-life, offering immunity for the entire tick season with a single spring administration. TNX-4800 avoids limitations of traditional Lyme vaccines and aims to block transmission of Borrelia from ticks to animals. The antibody could play a crucial role in preventing Lyme disease and addressing the lack of current FDA-approved prophylactics.
Tonix Pharmaceuticals is a biotechnology company with a focus on developing innovative treatments for various diseases. Their product portfolio includes TONMYATM, a non-opioid analgesic for fibromyalgia, and two treatments for acute migraines in adults. Tonix is also working on therapies for CNS disorders, immunology, immuno-oncology, rare diseases, and infectious diseases like Lyme. With a strong pipeline of products in development, Tonix aims to address unmet medical needs and improve patient outcomes.
Zembrace® SymTouch® and Tosymra® are prescription medicines for treating acute migraines in adults. They are not used for migraine prevention and may cause serious side effects like heart problems and medication overuse headaches. Patients should be cautious when using Zembrace and Tosymra, especially if they have certain risk factors or are taking other medications. These drugs can cause dizziness, weakness, or drowsiness, so patients should avoid driving or operating machinery if these side effects occur.
Read more at GlobeNewswire: Tonix Pharmaceuticals Announces Program Updates on Phase