Traws Pharma, Inc. announced significant progress in the development of its investigational one-dose influenza therapy, tivoxavir marboxil, for the treatment of H5N1 bird flu on December 23, 2024. Phase 1 dosing in healthy volunteers has been completed, demonstrating safety and tolerability.
Preclinical studies showed potent inhibition of drug-resistant and bird flu viruses in vitro. An in vivo study in mice, using H5N1 isolated from an infected dairy worker, resulted in complete survival and lung virus levels below the limit of quantitation after oral treatment with tivoxavir marboxil.
Topline Phase 1 data indicated that a single dose of tivoxavir marboxil maintained plasma drug levels consistently above the EC90 for longer than 23 days. The company expects to begin a Phase 2 study in the first half of 2025, expanding its influenza program to address the potential threat of bird flu.
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