Traws Pharma's Bird Flu Drug Tivoxavir Marboxil Presented at ICAR

28 March 2025
Traws Pharma, Inc., a biopharmaceutical company at the clinical stage, is making new strides in developing treatments for respiratory viral diseases. The company recently unveiled promising data concerning their product, tivoxavir marboxil (TXM), as a treatment for bird flu. This information was shared at the International Society for Antiviral Research conference in Las Vegas.

In a statement, Dr. C. David Pauza, the Chief Science Officer of Traws Pharma, emphasized the growing threat bird flu poses to human health. The spread of the virus in poultry and dairy farms heightens the risk for agricultural workers, necessitating an effective antiviral solution. TXM, according to recent studies, exhibits strong potential in battling bird flu by effectively suppressing both native and resistant virus strains. It also shows promise in reducing mortality rates and viral symptoms, demonstrating good tolerability and ease of use.

The data presented at the conference stem from laboratory, preclinical, and Phase 1 trials. These findings bolster the belief within Traws Pharma that TXM could be a powerful and safe treatment for bird flu, with potential applications for seasonal influenza as well. Looking forward, Traws Pharma aims to engage with the FDA to discuss the possibility of an accelerated approval process for TXM.

Werner Cautreels, CEO of Traws Pharma, expressed satisfaction with the opportunity to present these encouraging results to the international antiviral community. An investor update event is scheduled for March 31, 2025, to provide further insights into Traws Pharma’s ongoing antiviral programs.

The poster presented at the conference, titled "Tivoxavir marboxil, an Influenza Inhibitor Targeting Cap-dependent Endonuclease," highlighted the significant findings from the Phase 1 trial. The poster demonstrated TXM's ability to safely maintain therapeutic drug levels following a single dose, with excellent tolerability. In laboratory settings, TXM effectively suppressed various influenza strains, including resistant ones, achieving sub-nanomolar potency against H5N1, a variant of the influenza A virus.

The preclinical trials, conducted using a rodent challenge model, showed that TXM-treated mice had a 100% survival rate, with no virus-induced weight loss and significantly reduced lung viremia. In contrast, untreated mice succumbed to the virus by the sixth day of the study. These promising results align with previous data from similar studies conducted on ferrets.

Tivoxavir marboxil is designed as a single-dose treatment, distinguishing itself as a potential game-changer in the antiviral market. Its development aligns with the increasing demand for effective treatments against both seasonal influenza and potential pandemic outbreaks like bird flu. The market for seasonal influenza treatments is substantial, driven by health organizations and government tenders, and could see further growth with the threat of pandemics.

Traws Pharma’s focus extends beyond bird flu, with ongoing development of another antiviral, ratutrelvir, aimed at treating COVID-19. This investigational treatment targets the main protease of the virus, offering a potential therapeutic without the need for ritonavir.

In summary, Traws Pharma is advancing in the field of antiviral research with tivoxavir marboxil showing significant promise as a single-dose treatment for bird flu. The company’s efforts could mark a pivotal moment in addressing viral threats, showcasing a commitment to innovative therapies that respond to urgent global health challenges.

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