NEWTOWN, PA — Traws Pharma, Inc. (Nasdaq: TRAW) said it has completed enrollment in a 90-patient Phase 2 study testing its experimental oral COVID-19 treatment ratutrelvir against PAXLOVID®, reporting early clinical results that point to fewer adverse events, no viral rebound observed to date, and faster sustained symptom resolution.
The open-label study compares ratutrelvir, a ritonavir-free Mpro/3CL protease inhibitor, with PAXLOVID® in patients with mild-to-moderate COVID-19 and includes a separate arm for patients unable to take ritonavir-boosted therapies due to contraindications or drug–drug interactions. That group represents a significant population at elevated risk for severe disease and with limited treatment options, the company said.
Patients receiving ratutrelvir were dosed at 600 milligrams once daily for 10 days, while those in the comparator arm received PAXLOVID® at its approved regimen of nirmatrelvir plus ritonavir for five days. The trial evaluated patient-reported symptoms, safety, and real-world usability.
Chief Medical Officer Robert R. Redfield said the ongoing data analysis supports earlier findings that ratutrelvir may benefit a broader range of patients, including those who cannot receive ritonavir-boosted regimens. He cited favorable tolerability, shorter time to symptom resolution, and the absence of viral rebound events in treated patients as signals supporting continued clinical development.
Redfield added that the combination of extended dosing, early and sustained symptom improvement, and lack of rebound observed so far supports the hypothesis that ratutrelvir could play a role in reducing post-acute sequelae of SARS-CoV-2 infection, commonly known as Long COVID, by enabling earlier and more complete viral clearance.
Alongside the COVID-19 update, the company said it is advancing its tivoxavir marboxil program for influenza, positioning the drug as a potential once-monthly oral prophylactic treatment. In earlier Phase 1 studies, an unformulated version produced blood levels exceeding three times the EC50 against common seasonal influenza variants for up to 22 days, according to the company. A new compressed tablet formulation is expected to extend coverage to 28 days.
Chief Science Officer C. David Pauza said a planned bridging study in healthy volunteers is expected to confirm the extended exposure before the program moves into a seasonal influenza prophylaxis challenge study scheduled for June 2026 at hVIVO, a contract research organization specializing in human challenge trials.
Chief Executive Officer Iain Dukes said the parallel advancement of the company’s COVID-19 and influenza programs represents multiple value inflection points and could lead to new treatment and prevention options for clinically significant viral diseases.
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