Traws Pharma, Inc. announced on August 18, 2025, that it has received approval from the Human Research Ethics Committee (HREC) to proceed with a Phase 2 study evaluating ratutrelvir, its ritonavir-free treatment for newly diagnosed COVID subjects. The studies are planned to be initiated in the Southern Hemisphere.
The first trial will be a non-inferiority study comparing ratutrelvir against PAXLOVID®, assessing safety, infection rates, COVID symptoms, disease rebound, and the incidence of Long COVID development. A second, separate single-arm trial will evaluate the safety and efficacy of ratutrelvir in PAXLOVID®-ineligible patients, a vulnerable population with limited treatment options.
Traws Pharma expects to report top-line data from both Phase 2 studies by year-end 2025. This regulatory approval and clear timeline represent a significant inflection point for the ratutrelvir program, positioning it to address shortcomings of current COVID treatments, such as drug-drug interactions and the prevention of rebound and Long COVID.
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