Tonix Pharmaceuticals presented Phase 1 pharmacokinetic data for TNX-4800, supporting a two-dose regimen predicted to maintain protective serum levels above 10 µg/mL for 196 days in a planned adaptive Phase 2 study for Lyme disease prevention.
Key takeaways
Presented Phase 1 trial data for TNX-4800 at Global Lyme Alliance on May 15, 2026.
Simulations predict two 350 mg SC doses (Day 1 and 56) maintain serum above 10 µg/mL for 196 days, supporting six-month protection endpoint.
Days to below MECs: 10 µg/mL (196 days), 15 µg/mL (161 days), 20 µg/mL (136 days), 5 µg/mL (265 days).
Adaptive Phase 2 field study planned for first half of 2027, pending FDA agreement.
Phase 1 showed favorable safety, dose-proportional PK, and serum levels quantifiable up to 350 days at higher doses.
TNX-4800 is a long-acting anti-OspA monoclonal antibody licensed from UMass Chan Medical School.