Traws Pharma completed the clinical analysis of its 90‑patient, open‑label Phase 2 study that compared the investigational oral, ritonavir‑free COVID‑19 treatment ratutrelvir to the approved Paxlovid regimen. The study included a separate arm of 30 patients who were ineligible for Paxlovid because of drug‑drug interactions or contraindications.
Ratutrelvir produced a lower rate of treatment‑related adverse events—10 % versus 23.3 % in the Paxlovid arm—and no viral rebound events were observed. Symptom resolution was equivalent or faster in the ratutrelvir group, with a hazard ratio of 1.31 (95 % CI 0.78–2.20; p = 0.018) for faster resolution in the ineligible subgroup.
The data support a $1.5 billion‑plus market segment of patients who cannot receive Paxlovid, suggesting that a ritonavir‑free regimen could broaden access to a sizable portion of the COVID‑19 treatment market.
In parallel, Traws Pharma highlighted pre‑clinical progress for its other antiviral, tivoxavir marboxil. The tablet formulation achieved increased exposure and could provide 28‑day protection against seasonal influenza. The company plans to advance these findings into a human prophylaxis challenge study in the United Kingdom.
The U.S. FDA placed the company’s IND for tivoxavir marboxil on clinical hold because of concerns about mutagenicity data. Formal feedback is expected by March 16 2026. In response, Traws Pharma said it is working to mitigate the issue in its clinical development plan, noting that the hold does not affect ongoing or planned studies outside the United States.
The announcement was met with a negative market reaction as investors weighed the regulatory setback, which could delay the development of a key influenza candidate and impact the company’s overall pipeline strategy.
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