Traws Pharma Advances H5N1 Bird Flu Treatment with Promising Data

Traws Pharma (TRAW), a clinical-stage biotech firm focused on respiratory viral diseases, has reported significant progress in the development of its investigational treatment for H5N1 bird flu, tivoxavir marboxil. This breakthrough comes at a time when avian flu is increasingly recognized as a potential global health threat.

Dr. Robert R. Redfield, Chief Medical Officer at Traws Pharma and former CDC Director, highlighted the growing risks posed by avian influenza. “The spread of bird flu in animal populations, including mammals, raises the likelihood of human adaptation and subsequent transmission,” said Redfield. “With rising cases of human infections and severe illnesses, the possibility of an epidemic or pandemic cannot be ignored.”

Preclinical and Phase 1 Highlights
Tivoxavir marboxil has demonstrated strong efficacy in both laboratory and animal studies. In vitro experiments revealed the therapy’s ability to neutralize multiple strains of highly pathogenic H5N1 viruses. In an in vivo study, mice infected with H5N1—using a virus strain from a dairy worker—showed complete survival when treated with tivoxavir marboxil. Furthermore, the drug reduced lung virus levels to undetectable amounts, underscoring its antiviral potential.

Phase 1 trials, a key step in clinical development, also produced encouraging results. This randomized, double-blind, placebo-controlled study evaluated the safety, tolerability, and pharmacokinetics of a single dose in healthy adult volunteers. The treatment was well-tolerated with no adverse events linked to the drug. Notably, tivoxavir marboxil sustained blood levels above the EC90 threshold—required to inhibit 90% of viral activity—for over 23 days. Data on higher doses is forthcoming.

“Our findings in preclinical and Phase 1 settings demonstrate tivoxavir marboxil’s capacity to combat H5N1 effectively,” noted Dr. C. David Pauza, Chief Science Officer at Traws Pharma.

Future Development Plans
With Phase 1 trials completed, the company is gearing up for Phase 2 studies, expected to start in the first half of 2025. These will further explore the drug’s safety and efficacy in individuals exposed to or infected by H5N1.

CEO Werner Cautreels emphasized the therapy’s significance. “Tivoxavir marboxil could be a game-changer in addressing the urgent need for effective bird flu treatments,” he said.

Traws Pharma’s progress reinforces its commitment to combating respiratory diseases and addressing emerging public health challenges.

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