Clinical-stage biopharmaceutical company Traws Pharma Inc (NASDAQ: TRAW) on Monday announced progress in the development of its investigational one-dose influenza investigational therapy, tivoxavir marboxil, for treating H5N1 bird flu.

Current topline data from a Phase 1 trial showed that a single dose of tivoxavir marboxil maintained plasma drug levels consistently above the EC90 for more than 23 days, with topline data for a higher dose still to come. In preclinical studies tivoxavir marboxil demonstrated potent inhibition of drug-resistant influenza viruses, as well as potent inhibition of highly pathogenic bird flu viruses both in vitro and in vivo.

A Phase 2 study is expected to begin in the first half of 2025.

Robert R Redfield, MD, chief medical officer for Traws Pharma and former Director of the US Centers for Disease Control and Prevention (CDC), said: "The spread of avian influenza in wild and domestic animal populations, including mammals, brings increasing risk for adaptation to humans and subsequent spread in the population.

"Bird flu is an occupational hazard for poultry and dairy workers. With increasing numbers of human infections and recent reports of severe cases, we should be alert to the rising potential for epidemic or pandemic spread of bird flu."