NEWTOWN, PA — Traws Pharma, Inc. (NASDAQ: TRAW) said it has taken a key step toward federal preparedness planning by filing an investigational new drug application for its influenza candidate tivoxavir marboxil, while also reporting interim clinical data suggesting its COVID-19 antiviral ratutrelvir may outperform Pfizer’s Paxlovid in several important measures.
The company said the U.S. IND filing for tivoxavir marboxil, or TXM, clears the final hurdle for formal consideration by the Biomedical Advanced Research and Development Authority for potential inclusion in the nation’s strategic stockpile. TXM is a single-tablet, oral CAP-dependent endonuclease inhibitor being developed as a broad, pan-influenza therapy.
“This filing represents an important step toward formal consideration of TXM for influenza therapy and inclusion in the strategic national stockpile,” said C. David Pauza, Traws’ chief scientific officer, citing ongoing discussions with the U.S. Department of Health and Human Services on the drug’s role in future outbreak preparedness.
Separately, Traws released updated interim results from a Phase 2 study of ratutrelvir, an oral, ritonavir-free 3CL protease inhibitor for COVID-19, showing a differentiated profile versus PAXLOVID in patients with mild to moderate disease. The randomized, open-label study compared ratutrelvir directly with Paxlovid and included a separate arm of patients ineligible for ritonavir-boosted regimens due to contraindications or drug–drug interactions.
Among 50 patients included in the interim analysis, ratutrelvir-treated participants achieved sustained symptom resolution faster than those receiving Paxlovid, with median time to sustained alleviation of 12 days versus 14 days. Sustained alleviation was defined as relief of all symptoms for four consecutive days. No symptom or virologic rebound events have been observed to date in the ratutrelvir arm, while one rebound occurred in the Paxlovid comparator group shortly after completion of treatment.
Ratutrelvir was also better tolerated, the company said. Among patients who completed 28 days of follow-up, mild dyspepsia was the most common adverse event in the ratutrelvir group, reported in two patients, with no cases of dysgeusia or treatment discontinuation. In contrast, adverse events commonly associated with Paxlovid, including dysgeusia and dizziness, were reported in roughly 30% of comparator patients.
Importantly, the favorable safety and efficacy signals were recapitulated in patients ineligible for Paxlovid, a population often at higher risk for severe disease and with limited treatment options.
“These interim data confirm that ratutrelvir may provide a meaningful benefit across a broader range of patients,” said Robert R. Redfield, Traws’ chief medical officer, pointing to the absence of rebound events and faster symptom resolution as encouraging signals for continued development.
The Phase 2 study is nearing completion, with 95% of the planned 90-patient cohort enrolled and full enrollment expected in January 2026. Company executives said the findings support further evaluation of ratutrelvir not only for acute COVID-19, but potentially for reducing post-acute complications, including long COVID, pending confirmation in dedicated studies.
Chief Executive Officer Iain Dukes said the combined progress on tivoxavir marboxil and ratutrelvir positions Traws to play a role in both pandemic preparedness and next-generation antiviral treatment.
“Collectively, the interim data position ratutrelvir as a next-generation oral protease inhibitor,” Dukes said, highlighting its once-daily dosing, ritonavir-free administration, and applicability to patients unable to take existing therapies.
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