Traws Pharma's Bird Flu Drug Candidate, Tivoxavir Marboxil, Presented at ICAR

Core Viewpoint - Traws Pharma, Inc. has presented positive data supporting the potential of tivoxavir marboxil (TXM) as a treatment for bird flu at the International Society for Antiviral Research (ICAR 2025) conference, indicating its effectiveness and safety profile [1][2]. Company Overview - Traws Pharma is a clinical-stage biopharmaceutical company focused on developing novel therapies for respiratory viral diseases, including bird flu and seasonal influenza [8][9]. - The company aims to advance investigational antiviral agents that are effective against resistant virus strains, with a commitment to patient safety and simplified dosing regimens [8]. Product Development - Tivoxavir marboxil (TXM) is an investigational oral small molecule designed as a single-dose treatment for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease [5][9]. - Positive preclinical data indicate that a single dose of TXM demonstrated a therapeutic effect against H5N1 bird flu, with laboratory studies showing potent suppression of various influenza viruses [6][7]. Clinical Trial Results - Data from a rodent challenge model showed that 100% of mice treated with TXM survived, with no virus-induced weight loss and significant reductions in lung viremia, while all untreated animals succumbed by study day 6 [6]. - Phase 1 trial results indicated that a single dose of TXM maintained plasma blood levels at EC90 for approximately three weeks, demonstrating good overall tolerability [6]. Future Plans - The company plans to meet with the FDA to discuss next steps, including the potential for an accelerated path to approval for TXM [2]. - An investor call is scheduled for March 31, 2025, to provide updates on Traws' antiviral programs [2][5].