Clinical-stage biopharmaceutical company Traws Pharma, Inc. (NASDAQ: TRAW) on Thursday reported final results from a 92-patient Phase 2a study of ratutrelvir, its investigational once-daily oral COVID-19 treatment, and said a bridging study of its influenza candidate tivoxavir marboxil (TXM) met its objectives.
In patients eligible for PAXLOVID, ratutrelvir was found to achieve a median time to sustained symptom resolution of 13.5 days versus 14.5 days for PAXLOVID, with similar declines in viral RNA, no virologic rebound through Day 28, and fewer treatment-related adverse events. Among PAXLOVID-ineligible patients, ratutrelvir produced a similar rate of viral clearance, symptom resolution in 14.0 days, and no treatment-related adverse events.
Traws plans to discuss a registration strategy with the US Food and Drug Administration focused on high-risk adult COVID-19 patients who are ineligible for PAXLOVID, including a potential adaptive Phase 2b/pivotal programme and Fast Track designation.
The company also completed a bridging study of a compressed tablet formulation of TXM, an investigational long-acting influenza prophylactic, which showed comparable exposure to the powder-in-capsule formulation and supported the potential for once-monthly dosing and further efficacy studies.
Traws also completed toxicology retesting for TXM, including two independent rat Pig-a gene mutation studies that found no mutagenic effects at doses up to 500 mg/kg. The company said the results support an updated regulatory submission planned for the fourth quarter of 2026.
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