NEWTOWN, PA — Traws Pharma, Inc. (NASDAQ: TRAW) shared encouraging findings on its investigational antiviral drug, tivoxavir marboxil (TXM), during the International Society for Antiviral Research (ICAR 2025) in Las Vegas. The data underscores TXM’s potential as a treatment for bird flu, offering hope for addressing this pressing public health challenge.
Preclinical studies demonstrated that TXM effectively suppressed resistant strains of influenza, with sub-nanomolar potency against influenza A (H5N1). Rodent challenge models showed that mice treated with TXM exhibited 100% survival, minimal lung viremia, and no virus-induced weight loss, while untreated animals succumbed to infection within six days.
Results from Phase 1 trials further supported the treatment’s promise. A single dose of TXM maintained plasma concentrations at therapeutic levels for approximately three weeks, with notable tolerability across a wide dosage range. This suggests TXM could provide effective, long-lasting protection in highly virulent flu strains.
“Bird flu has emerged as a potential threat to human health. Extensive spread in poultry and dairy farms have increased the exposure risk for agricultural workers,” said C. David Pauza, PhD, Chief Science Officer of Traws Pharma. “We believe an effective antiviral agent for bird flu needs to potently suppress native and resistant viruses and provide protection against mortality and viral disease, with good overall tolerability and ease of use. The positive data presented at ICAR, from laboratory, preclinical and Phase 1 studies, reinforce our view that TXM meets that target profile and has the potential to be a potent, effective and safe treatment for bird flu, with broad applicability to seasonal flu.”
Traws Pharma expects to engage the FDA in discussions regarding potential approval pathways for TXM.
“We were pleased to have the opportunity to share the promising TXM results in bird flu with the international antiviral community during the poster session at ICAR,” said Werner Cautreels, PhD, Chief Executive Officer of Traws Pharma. “We look forward to updating investors on Traws’ antiviral programs during a virtual event on Monday, March 31, 2025, at 10:00 AM ET.”
With its ability to target multiple influenza strains and resistant viruses, TXM has the potential to reshape bird flu management, offering an innovative step forward in antiviral treatments.
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