NEWTOWN, PA — Traws Pharma, Inc. (NASDAQ: TRAW) announced receipt of key guidance from the U.S. Food and Drug Administration (FDA) regarding the development of its investigational antiviral, tivoxavir marboxil (TXM), for use against both bird flu and seasonal influenza. The written responses, which followed a Type B pre-Investigational New Drug (IND) meeting, provide detailed feedback on development pathways, including the use of the FDA’s Animal Rule. This regulatory framework enables drug approval in cases where human trials are either unethical or impractical.
“The FDA has provided detailed feedback on the development paths for approval, including a combined clinical study enrolling seasonal flu and bird flu-infected subjects, as such infections occur. We are requesting a Type D meeting with the FDA to specify next steps and look forward to working closely with the Agency to develop TXM for bird flu and seasonal flu,” stated Dr. C. David Pauza, Chief Science Officer for Traws Pharma.
TXM is a single-dose oral CAP-dependent endonuclease inhibitor designed to treat various influenza strains. Preclinical trials have shown promising results, with the drug demonstrating therapeutic effects in three separate animal models of avian influenza.
“The consistent finding of therapeutic effects of TXM in three animal models of bird flu increases our confidence that this compound should be rapidly progressed for stockpiling and pandemic readiness by government agencies,” added Dr. Robert R. Redfield, Chief Medical Officer at Traws Pharma and former Director of the U.S. Centers for Disease Control and Prevention (CDC). “To that end, we have initiated a dialog with the Biomedical Advanced Research and Development Authority (BARDA), the responsible agency for stockpiling for pandemic preparedness in the United States, and we plan to engage with respective international regulatory agencies for the same purpose. With the known history that previous H5N1 virus outbreaks in human populations are associated with death rates of up to 50%, we believe that these actions should be pursued with great urgency.”
Beyond the feedback from the FDA, Traws Pharma is pursuing discussions with regulatory bodies and health agencies worldwide to ensure TXM’s potential inclusion in pandemic preparedness efforts. These discussions align with the company’s broader goal of stockpiling the drug as a strategic countermeasure against future influenza outbreaks, particularly H5N1 avian flu.
“This initial interaction with the FDA has helped guide the development of TXM as a broad therapeutic against pandemic and seasonal influenza,” said Iain Dukes, Interim CEO of Traws Pharma. “We are committed to progressing the process for stockpiling TXM to prevent any pandemic outbreaks associated with bird flu.”
Tivoxavir marboxil promises a notable market opportunity, given its potential for addressing both seasonal and pandemic flu strains. With seasonal flu already driving billions of dollars in annual antiviral expenditures worldwide, the drug’s future role in pandemic preparedness could significantly expand its impact as governments seek fast and effective countermeasures for emerging threats.
Traws Pharma’s announcement underscores the critical nature of ongoing drug development when faced with infectious diseases that can escalate into global health emergencies.
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