NEWTOWN, PA — Traws Pharma, Inc. (NASDAQ: TRAW) announced encouraging topline results from preclinical studies evaluating tivoxavir marboxil (TXM) as a potential treatment for H5N1 bird flu. The investigational oral therapy, designed as a single-dose treatment, demonstrated significant reductions in lung viremia and prevention of flu-induced weight loss in non-human primates (NHPs), reinforcing its potential to address the global bird flu threat.
The study involved a group of ten NHPs, split evenly into treated and control groups. After being exposed to a non-lethal dose of H5N1, the TXM-treated animals received a human-equivalent dose of 480 mg. While untreated animals exhibited elevated lung viremia, with levels rising to 1×10⁷ infectious particles per milliliter, TXM-treated subjects maintained virus levels consistently below detectability. Additionally, untreated primates experienced an average body weight loss of 4.2% over ten days, whereas TXM-treated animals sustained or gained weight (p<0.004), underscoring the drug’s antiviral activity.
“Bird flu continues to be a threat to human health. In addition to the ongoing plague of bird flu in wild birds and mammals, extensive spread in poultry and dairy farms has increased the exposure risk for agricultural workers. Every contact between humans and infected animals increases the risk that bird flu will evolve and spread in the human population,” said Robert R. Redfield, MD, Chief Medical Officer for Traws Pharma and former Director of the U.S. Centers for Disease Control and Prevention (CDC). “With positive results from three animal models, and acknowledging the substantial risk to human health, we are committed to seeking FDA feedback on the regulatory path for TXM in H5N1 bird flu.”
The findings were consistent with earlier preclinical studies conducted in ferrets and mice. TXM treatment showed improved survival and suppressed viral load across these models, further supporting its potential as a therapeutic option.
Traws Pharma plans to engage with the U.S. Food and Drug Administration (FDA) later this year to explore regulatory options, including the “Animal Rule.” This pathway allows drug approval based on animal model efficacy and safety data in cases where human clinical trials would be unethical or impractical.
“The Company intends to meet with the FDA in H1 2025 to align on a path forward, including the potential for accelerated approval utilizing the ‘Animal Rule,’ wherein safety studies in healthy human volunteers plus effectiveness data in animal models are used to support drug approval,” said Werner Cautreels, PhD, Chief Executive Officer for Traws Pharma. “We will host an Investor Event on Monday, March 31, 2025 at 10:00 AM ET to present an overview of preclinical and human data on TXM and potential next steps towards approval.”
With the threat of H5N1 mutations and its implications for global health, Traws Pharma is positioning TXM as a significant step forward in pandemic preparedness, addressing an unmet need for effective bird flu treatments. The company plans to accelerate development to bring this promising therapy closer to public availability.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.