NEWTOWN, PA — Traws Pharma Inc. (NASDAQ: TRAW) has deferred a planned Phase 2a human influenza challenge study of its lead antiviral candidate tivoxavir marboxil after receiving unfavorable feedback from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency, creating a setback for the company’s influenza development program.
The regulatory review halted plans to test the drug candidate in a controlled human influenza study, delaying a key step in the clinical evaluation of the therapy.
The decision affects tivoxavir marboxil, or TXM, which Traws has been developing as a potential treatment and preventive therapy for influenza, including highly pathogenic avian influenza strains.
The company indicated it continues to view influenza as a significant commercial and public health opportunity and plans to advance alternative antiviral compounds with pharmacokinetic characteristics similar to TXM.
Chief Executive Officer Iain Dukes said the regulatory feedback affects the timing of the planned study but does not alter the company’s strategy of pursuing long-acting influenza antivirals.
“While the recent regulatory feedback affects the timing of our planned challenge study, it does not change our conviction in the underlying scientific rationale,” Dukes said.
Traws reported that TXM demonstrated efficacy in multiple animal models of avian influenza and produced pharmacokinetic results that supported further investigation as a treatment and preventive option.
Chief Science Officer C. David Pauza said the compound may still have potential utility in a future bird flu outbreak and for use among high-risk populations, despite the regulatory setback.
The company also emphasized that it maintains a portfolio of backup influenza antiviral candidates designed to retain the long-duration exposure profile observed with TXM while addressing regulatory concerns raised during the review process.
Chief Medical Officer Robert Redfield, the former director of the U.S. Centers for Disease Control and Prevention, noted that seasonal influenza and avian influenza continue to pose significant health risks, particularly for elderly and immunocompromised patients.
Traws said its current cash resources are expected to fund operations through the first quarter of 2027 as it advances alternative influenza programs.
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