Traws Pharma, Expert Systems: Breakthrough in H5N1Bird Flu antiviral program

Expert Systems announced a significant milestone in a development of Traws Pharma’s (TRAW) H5N1 antiviral program. The investigational drug, Tivoxavir Marboxil, has shown encouraging results as a single-dose treatment for H5N1 avian influenza, representing a potentially pivotal advance in addressing this serious health challenge. Tivoxavir Marboxil, an oral cap-dependent endonuclease inhibitor, targets a highly conserved influenza protein, demonstrating broad-spectrum efficacy against various flu strains, including avian influenza. Preclinical studies have highlighted its potent activity against drug-resistant and highly pathogenic bird flu viruses, both in vitro and in vivo. In a recent randomized, double-blind, placebo-controlled Phase 1 clinical trial, the safety, tolerability, and pharmacokinetics of single ascending doses of Tivoxavir Marboxil were evaluated in healthy, influenza-negative adult volunteers. The trial reported no treatment-related adverse events. Notably, a single dose maintained plasma drug levels above the effective concentration for over 23 days, indicating the potential for sustained efficacy with a one-time administration. With the completion of Phase 1 trials, plans are underway to initiate Phase 2 efficacy studies in the first half of 2025. This brings Tivoxavir Marboxil closer to becoming a viable treatment option for H5N1 bird flu, addressing a critical need in global health.