According to the preclinical studies, the therapy inhibited drug-resistant influenza viruses, including the highly pathogenic avian flu strains. Credit: QINQIE99/Shutterstock.

Traws Pharma has completed the Phase I clinical trials of tivoxavir marboxil, a single-dose drug for treating or preventing H5N1 bird flu.

The randomised, placebo-controlled, double-blind trial evaluated the pharmacodynamics (PD), tolerability, pharmacokinetics (PK), and safety of escalating doses in healthy and influenza-negative adult volunteers. 

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The four dose levels of the therapy were reported to be well-tolerated by the subjects, and no treatment-related adverse events were observed.

Traws Pharma chief science officer David Pauza said: “Topline data from the Phase I study demonstrated the safety and tolerability of tivoxavir marboxil in humans at levels of exposure that have demonstrated potent inhibition of H5N1, and informs dose selections for further testing in relevant animal models of bird flu.

“The combined clinical and animal model data package will guide our upcoming regulatory meetings as we advance this product and, hopefully, provide an important medical countermeasure against bird flu.”

The drug is designed to block the CAP-dependent endonuclease (CEN) protein in the influenza virus.

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In preclinical studies, both in vitro and in vivo, Tivoxavir marboxil demonstrated potent inhibition of drug-resistant influenza viruses, including the highly pathogenic avian flu strains.

Various concluded and ongoing studies are currently being assessed to evaluate the effect of a single dose of tivoxavir marboxil against bird flu infection.

Traws Pharma focuses on developing oral small molecule therapies targeting respiratory viral conditions.

Apart from tivoxavir marboxil, the company’s respiratory disease programme includes ratutrelvir, a candidate for Covid treatment targeting the Mpro protease, which does not require co-administration with ritonavir.