Traws Pharma announced positive topline results from a ferret study of tivoxavir marboxil, a single-dose oral antiviral for bird flu. The study, using a strain of H5N1 isolated from a Texas dairy worker, showed the drug suppressed disease and reduced viral load in the lungs, mirroring earlier findings in a mouse model. The company also plans to initiate a similar study in non-human primates.
These findings are crucial given the rising incidence of bird flu in poultry and dairy cattle, coupled with increasing human exposures and one fatality in the US. A successful antiviral treatment for bird flu could significantly impact public health by offering a proactive measure to contain outbreaks and mitigate the risk of wider human transmission. This would also strengthen global pandemic preparedness efforts.
The positive preclinical data in ferrets strengthens the case for tivoxavir marboxil as a potential one-time treatment. Traws Pharma plans to discuss an accelerated approval pathway with the FDA under the “Animal Rule” following the completion of the non-human primate study. The company believes tivoxavir marboxil represents a significant market opportunity given the potential multi-billion dollar market for influenza antivirals.
These positive results pave the way for further clinical development of tivoxavir marboxil. Pending positive data from the non-human primate study and subsequent FDA discussions, this drug could potentially become a critical tool in combating the growing threat of bird flu, not only for individual patients but also for global public health. This could position Traws Pharma as a key player in the antiviral market.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
