Traws Pharma, Inc. announced positive topline Phase 1 safety and pharmacokinetic results for its investigational one-dose influenza therapy, tivoxavir marboxil, on October 8, 2024. The dose-ranging study in healthy volunteers demonstrated good overall tolerability.
A single dose of tivoxavir marboxil maintained plasma drug levels consistently above the EC90 for more than five days and within the predicted therapeutic window. Preclinical data also showed potent inhibition of drug-resistant influenza viruses and highly pathogenic bird flu viruses.
The company plans to advance the program to a Phase 2 study in the first half of 2025, with the identified Phase 2 dose. Tivoxavir marboxil is designed as an inhibitor of the CAP-dependent endonuclease, a highly conserved influenza protein, positioning it as a potential broad-spectrum, single-dose treatment for seasonal and pandemic influenza.
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