Traws Pharma, Inc. announced on January 23, 2025, the completion of Phase 1 clinical studies for its investigational one-dose influenza therapy, tivoxavir marboxil, for the treatment or prevention of H5N1 bird flu. The Phase 1 trial, a randomized, double-blind, placebo-controlled study, assessed the safety, tolerability, and pharmacokinetics of ascending doses in healthy adult volunteers.
The study evaluated four dose levels, with no significant treatment-related adverse events reported. Topline data demonstrated that tivoxavir marboxil was safe and well-tolerated in humans at exposure levels that have shown potent inhibition of H5N1 in preclinical studies.
The pharmacokinetic data from the completed Phase 1 study supports accelerated development of tivoxavir marboxil and informs dose selections for further testing in relevant animal models of bird flu. The company believes these data, combined with animal model results, will guide upcoming regulatory meetings to advance the product as a potential medical countermeasure against bird flu.
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