Tonix Pharmaceuticals says on track to initiate Phase 2 study of TNX-4800

Tonix Pharmaceuticals (TNXP) announced presentation of Phase 1 data and plans for an adaptive Phase 2 field study of TNX-4800 for the prevention of Lyme disease in the U.S., at the 4th Annual Ticks and Tickborne Diseases Symposium. The Phase 2 study is expected to initiate in the first half of 2027, pending FDA agreement. The Phase 1 study was conducted by a team at UMass Chan Medical School led by Mark S. Klempner, MD, Professor of Medicine at UMass Chan and an inventor of TNX-4800. The adaptive Phase 2 field study is being planned by Tonix, which licensed TNX-4800 from UMass Chan Medical School in 2025. “We plan to initiate an adaptive Phase 2 field study in the first half of 2027 pending FDA agreement,” said Seth Lederman, MD, CEO of Tonix Pharmaceuticals. The company plans to study TNX-4800 in a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study to evaluate the efficacy of a two-dose regimen of TNX-4800 SC, in preventing the first occurrence of confirmed Lyme disease during the primary efficacy surveillance period. The two-dose regimen of TNX-4800 was selected for the Phase 2 field study based on the pharmacokinetic results of the Phase 1 study. Each fixed dose is expected to provide exposures comparable to the 5 mg/kg dose evaluated in Phase 1. The first dose will be administered in the Spring and the second booster dose will be administered two months later. Participants will include adolescents and adults 16 years of age and older in Lyme-endemic areas in the U.S. The primary endpoint will be the prevention of Lyme disease for six months following the initial dose. The company has scheduled a Type C meeting with the FDA early in the third quarter of 2026 to discuss the planned adaptive Phase 2 field study design. The company expects to have Good Manufacturing Practice investigational product available for clinical testing in early 2027.