Tonix plans adaptive Phase 2 trial of TNX-4800 antibody to prevent Lyme disease, targets Q1 2027 start

• Tonix received FDA Type C meeting minutes supporting plans for an adaptive Phase 2 field study of TNX-4800 to prevent Lyme disease.
• No clinical results were presented; the Phase 2 study is planned to start in Q1 2027, pending final protocol clearance.
• Trial design aligns on a randomized, placebo-controlled study of about 3,300 adults over two Lyme seasons.
• Study aims to show whether the long-acting antibody can prevent Lyme disease across the season, with safety tracked for 52 weeks.
• Most enrollment is expected in the 2028 season; enrollment could extend into 2029 if Lyme incidence runs below expectations.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Tonix Pharmaceuticals Holding Corp. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202608030700PRIMZONEFULLFEED9802358) on August 03, 2026, and is solely responsible for the information contained therein.