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Tonix Pharmaceuticals Holding Corp. announced receipt of official minutes from a Type C meeting with the U.S. Food and…
TNXPTonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals Holding Corp. announced receipt of official minutes from a Type C meeting with the U.S. Food and Drug Administration regarding its adaptive Phase 2 field study for TNX-4800, a monoclonal antibody intended to prevent Lyme disease in adults. The FDA aligned with the company on a randomized, placebo-controlled design enrolling approximately 3,300 participants from Lyme-endemic areas over two seasons. The primary efficacy endpoint is prevention at six months post-dose, with safety evaluated over 52 weeks. Participants will receive TNX-4800 450 mg subcutaneously or placebo in a two-dose regimen spaced three months apart. Investigational product delivery to study sites is scheduled for the first quarter of 2027, with enrollment expected primarily in the 2028 season. Tonix Pharmaceuticals Holding Corp. operates as a commercial-stage biotechnology company focused on central nervous system disorders, infectious diseases, immunology conditions, and rare diseases.