other material
confidence high
sentiment positive
materiality 0.70
Tonix reports Phase 1 PK data for TNX-4800 Lyme antibody; two-dose regimen supports 6-month protection
Tonix Pharmaceuticals Holding Corp.
- TNX-4800 Phase 1 PK data presented at Global Lyme Alliance; two-dose 350 mg SC regimen (Day 1, Day 56) modeled.
- Simulations predict days above MEC: 10 µg/mL (196 days), 15 µg/mL (161 days), 20 µg/mL (136 days), 5 µg/mL (265 days).
- Data supports maintaining serum level above 10 µg/mL for six months after initial dose, proposed Phase 2 primary endpoint.
- Adaptive Phase 2 field study planned for first half of 2027, pending FDA agreement.