Traws Pharma, Inc. announced on June 30, 2025, multiple regulatory submissions related to its antiviral pipeline, signaling significant progress in advancing its lead candidates. The company submitted a Phase 2 protocol to the Human Research Ethics Committee (HREC) to evaluate tivoxavir marboxil (TXM) in a combined seasonal and bird flu study in the Southern Hemisphere.
This proposed TXM study will include a dose-ranging, non-inferiority comparison to XOFLUZA® in seasonal influenza patients, along with a separate single arm to evaluate TXM in patients infected with H5N1 bird flu. The study is expected to enroll subjects in Australia and selected countries in Southeast Asia, where human bird flu infection rates are high.
Additionally, Traws submitted briefing documents to the FDA for a Type D meeting request to continue discussions on a potential accelerated approval path for TXM for bird flu. For its COVID-19 candidate, ratutrelvir, a Phase 2 non-inferiority study protocol was submitted to HREC, comparing it to PAXLOVID® in newly diagnosed COVID patients, with endpoints including disease rebound and Long COVID incidence. A separate arm will evaluate ratutrelvir in PAXLOVID®-ineligible patients.
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