NEWTOWN, PA — Traws Pharma, Inc. (NASDAQ: TRAW) has announced the successful completion of Phase I clinical trials for tivoxavir marboxil, an investigational one-dose treatment aimed at combating H5N1 bird flu. The study marks a significant milestone in addressing a growing global health threat.
The Phase I trial, conducted in healthy, influenza-negative adult volunteers, demonstrated the drug’s safety and tolerability. No significant treatment-related adverse events were reported across the four dose levels tested. Pharmacokinetic data reinforced tivoxavir’s potential for further development as both a treatment and preventive measure against H5N1.
“We believe that our clinical data in healthy volunteers support accelerated development of tivoxavir marboxil in response to the growing threat of bird flu,” said Werner Cautreels, PhD, Chief Executive Officer of Traws Pharma.
Tivoxavir targets the CAP-dependent endonuclease (CEN) protein, a highly conserved feature in influenza viruses, making it effective against both seasonal and highly pathogenic strains of flu, including H5N1. Preclinical studies have already shown potent inhibition of these viruses in both laboratory and animal models.
“The first U.S. death from the bird flu and the spread into commercial poultry farms highlight a growing threat to public health,” said Robert R. Redfield, MD, Chief Medical Officer at Traws Pharma and former CDC Director. “We believe that new antiviral therapies, with proven activity against the H5N1 bird flu, are needed to address this potential threat. Continued circulation of this H5N1 virus in wild birds and mammals, plus spread of the virus from cattle or poultry to agricultural workers, sustains the risk for virus adaptation and human-to-human transmission.”
The Phase I findings set the stage for further regulatory discussions and animal model studies to refine dosing strategies. “Topline data from the Phase I study demonstrated safety and tolerability of tivoxavir marboxil in humans at levels of exposure that have demonstrated potent inhibition of H5N1,” explained C. David Pauza, PhD, Chief Science Officer at Traws Pharma. “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.”
With the H5N1 bird flu posing a persistent and evolving threat, tivoxavir marboxil’s successful trial results point to its potential as a game-changing tool in pandemic and seasonal influenza management. Regulatory discussions to pave the way for further development are expected in the coming months.
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