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Traws Pharma Announces Completion of Phase I Studies with Tivoxavir Marboxil, a Single Dose Oral Investigational Drug for the Treatment and Prevention of H5N1 Bird Flu
Phase I completed in healthy volunteers with pharmacokinetic data supporting dosing for both therapeutic and further development for bird flu prevention
About this update from Traws Pharma, Inc.
[{"type":"text","content":"Phase I completed in healthy volunteers with pharmacokinetic data supporting dosing for both therapeutic and further development for bird flu prevention\nNEWTOWN, Pa., Jan. 23, 2025 /PRNewswire/ -- Traws Pharma, Inc. (NASDAQ: TRAW) (\"Traws Pharma\", \"Traws\" or \"the Company\"), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of respiratory viral diseases, today announced completion of Phase I clinical studies of its investigational one-dose influenza (flu) therapy, tivoxavir marboxil (tivoxavir), for the treatment or prevention of H5N1 bird flu.\n\n\"We believe that our clinical data in healthy volunteers support accelerated development of tivoxavir marboxil in response to the growing threat of bird flu,\" said Werner Cautreels, PhD, Chief Executive Officer of Traws Pharma.\n\"The first U.S. death from the bird flu2 and the spread into commercial poultry farms highlight a growing threat to public health,\" 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). \"We believe that new antiviral therapies, with proven activity against the H5N1 bird flu, are needed to address this potential threat. Continued circulation of this H5N1 virus in wild birds and mammals, plus spread of the virus from cattle or poultry to agricultural workers, sustains the risk for virus adaptation and human to human transmission.3\"\n\"Topline data from the Phase I study demonstrated safety and tolerability of tivoxavir marboxil in humans at levels of exposure that have demonstrated potent inhibition of H5N1 and informs dose selections for further testing in relevant animal models of bird flu,\" said C. David Pauza, PhD, Chief Science Officer for Traws Pharma. \"The combined clinical and animal model data package will guide our upcoming regulatory meetings as we advance this product and, hopefully, provide an important medical countermeasure against bird flu.\"\nTopline Phase I ResultsThe Phase I trial was a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ascending doses of one-time tivoxavir marboxil treatment in healthy, influenza-negative, adult volunteers. \nNo significant treatment related adverse events were repo...