Tivoxavir Marboxil Shows Potent Protection Against H5N1 in Preclinical and Early Clinical Studies
Traws Pharma (TRAW), a clinical-stage biopharmaceutical company, has announced significant progress in the development of its investigational therapy, tivoxavir marboxil, aimed at treating H5N1 bird flu. This advancement comes as the global health community grows increasingly concerned about the potential for avian influenza to adapt to humans and spark widespread outbreaks.
According to Robert R. Redfield, MD, Chief Medical Officer at Traws Pharma and former Director of the U.S. Centers for Disease Control and Prevention (CDC), the recent rise in avian flu cases highlights the importance of developing effective treatments. “The spread of avian influenza in wild and domestic animal populations, including mammals, increases the risk of adaptation to humans and subsequent population spread,” Redfield explained. “With growing numbers of human infections, we must stay vigilant against the potential for epidemic or pandemic outbreaks.”
Promising Preclinical and Clinical Data
Tivoxavir marboxil has shown potent antiviral activity in both preclinical and clinical studies. Laboratory testing demonstrated its ability to inhibit multiple isolates of the highly pathogenic H5N1 avian influenza virus. Notably, in a mouse model using a virus strain isolated from a dairy worker, oral administration of tivoxavir marboxil after infection led to complete survival and a reduction of virus levels in the lungs below detectable limits.
“Our findings from preclinical studies, including in vivo experiments, underscore tivoxavir marboxil’s potential to suppress viral replication and protect against severe outcomes of H5N1 infection,” stated C. David Pauza, PhD, Chief Science Officer at Traws Pharma.
Topline results from the Phase 1 trial further support the drug’s potential. The randomized, double-blind, placebo-controlled study evaluated safety, tolerability, and pharmacokinetics in healthy volunteers. No treatment-related adverse events were reported. A single dose of tivoxavir marboxil maintained plasma drug levels above the EC90—sufficient to inhibit 90% of viral activity—for more than 23 days. Additional data on higher doses is expected soon.
Looking Ahead to Phase 2
With Phase 1 trials completed, Traws Pharma is preparing for Phase 2 studies, set to begin in the first half of 2025. These trials will focus on further evaluating the drug’s efficacy and safety in individuals exposed to or infected with H5N1.
CEO Werner Cautreels, PhD, emphasized the potential impact of the therapy, particularly given the absence of targeted, one-dose treatments for H5N1. “The encouraging data from both preclinical and Phase 1 studies position tivoxavir marboxil as a promising candidate in addressing the threat of bird flu,” Cautreels remarked.
As Traws Pharma expands its influenza program, the company remains committed to combating respiratory viral diseases, particularly those with the potential for significant public health consequences. The advancements in tivoxavir marboxil’s development bring hope for an effective countermeasure against the growing threat of avian influenza.
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