NEWTOWN, PA — Traws Pharma, Inc. (NASDAQ: TRAW) has unveiled encouraging preclinical results for its experimental antiviral drug, tivoxavir marboxil, in combating H5N1 bird flu. Using a ferret model, widely considered a strong indicator of human influenza responses, the study demonstrated significant disease suppression and a reduction in viral loads following a single dose.
The ferret data builds on findings from a December 2024 murine study, further validating the potential of tivoxavir marboxil as a treatment for bird flu. The current study used the A/Texas/37/2024 H5N1 virus, an isolate from a Texas dairy worker, and showed that the drug increased survival rates while reducing the virus’s impact within the lungs and nasal tissues.
“Tivoxavir marboxil shows promise in inhibiting disease after H5N1 infection,” stated Dr. C. David Pauza, Chief Scientific Officer for Traws Pharma. He emphasized that the work not only enhances understanding of the disease process but also informs dosing requirements for potential human applications.
The urgency of such developments was underscored by Dr. Robert R. Redfield, Chief Medical Officer for Traws Pharma and former CDC Director. “The continued rise in bird flu cases among poultry and livestock, coupled with increased human exposures and the recent fatality in the U.S., highlights the escalating need for effective antiviral interventions,” Redfield explained.
Expanding Studies and Accelerated Approval Goals
Building on these results, Traws Pharma is advancing its research with a non-human primate study, expected to deliver results in early 2025. The company has announced plans to approach the FDA under the “Animal Rule,” which allows approval of drugs based on efficacy in animal models when human trials are not feasible, such as for diseases with high mortality risks.
The findings are anticipated to shape discussions with regulators, with CEO Werner Cautreels noting plans for a Virtual Investor Update on March 31, 2025, to provide a comprehensive overview of the bird flu program.
A Critical Step in Addressing Bird Flu
The announcement comes as cases of H5N1 bird flu continue to rise globally, posing significant risks to both animals and humans. With tivoxavir marboxil progressing through rigorous tests, Traws Pharma’s work represents a vital advancement in developing treatments for one of the most pressing zoonotic threats in recent years.
If successful, this antiviral could become a key tool in preventing outbreaks and mitigating the impact of H5N1 infections, offering hope for improved public health preparedness and response.
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