Clinical TrialMay 15, 2026, 09:32 AM
Tonix Pharma Presents Positive TNX-4800 Phase 1 Data; Plans Phase 2 in 2027
AI Summary
Tonix Pharmaceuticals presented positive pharmacokinetic data from its Phase 1 trial for TNX-4800, a product candidate for Lyme disease, at the Global Lyme Alliance. The data supports the feasibility of a two-dose 350 mg regimen maintaining protective serum levels for six months, which is the proposed primary endpoint for the upcoming Phase 2 study. The company plans to initiate an adaptive Phase 2 field study for TNX-4800 in the first half of 2027, pending agreement by the U.S. Food and Drug Administration.
Key Highlights
- Tonix Pharma presented Phase 1 trial data for its TNX-4800 product candidate for Lyme disease.
- Simulations predict a two-dose 350 mg regimen maintains serum levels above 10 µg/mL for 196 days.
- The regimen is predicted to maintain serum levels above 15 µg/mL for 161 days.
- The regimen is predicted to maintain serum levels above 20 µg/mL for 136 days.
- The regimen is predicted to maintain serum levels above 5 µg/mL for 265 days.
- Data supports maintaining minimal mean serum levels above 10 µg/mL for six months, the proposed primary endpoint.
- Tonix Pharma plans an adaptive Phase 2 field study for TNX-4800 in H1 2027, pending FDA agreement.
- The Phase 1 study showed TNX-4800 was safe and well-tolerated with no treatment-related serious adverse events.
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