Traws Pharma Announces Clinical Results for Ratutrelvir with Promising Efficacy
- Significant Clinical Results: Traws Pharma completed a 90-patient clinical trial of ratutrelvir, revealing a notable reduction in adverse events compared to PAXLOVID®, with only 10% versus 23.3%, indicating ratutrelvir's superior safety profile in treating mild-to-moderate COVID-19 patients.
- Faster Symptom Resolution: In PAXLOVID®-ineligible patients, ratutrelvir demonstrated quicker symptom resolution with a hazard ratio of 1.31 (95% CI: 0.78-2.20, p=0.018), highlighting its potential advantage in clinical applications and offering effective treatment options for high-risk patients.
- Progress on Tivoxavir Marboxil: Traws Pharma's tivoxavir marboxil showed a 30% increase in drug exposure in preclinical analysis compared to the prototype formulation, with predicted 28-day protection against influenza, advancing its development as a seasonal flu prophylactic.
- FDA Clinical Hold: Although the IND application for tivoxavir marboxil is on clinical hold due to mutagenicity concerns, Traws Pharma is actively addressing these issues to ensure its clinical development plan remains unaffected, demonstrating the company's resilience in navigating regulatory challenges.
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- Significant Clinical Results: Traws Pharma completed a 90-patient clinical trial of ratutrelvir, revealing a notable reduction in adverse events compared to PAXLOVID®, with only 10% versus 23.3%, indicating ratutrelvir's superior safety profile in treating mild-to-moderate COVID-19 patients.
- Faster Symptom Resolution: In PAXLOVID®-ineligible patients, ratutrelvir demonstrated quicker symptom resolution with a hazard ratio of 1.31 (95% CI: 0.78-2.20, p=0.018), highlighting its potential advantage in clinical applications and offering effective treatment options for high-risk patients.
- Progress on Tivoxavir Marboxil: Traws Pharma's tivoxavir marboxil showed a 30% increase in drug exposure in preclinical analysis compared to the prototype formulation, with predicted 28-day protection against influenza, advancing its development as a seasonal flu prophylactic.
- FDA Clinical Hold: Although the IND application for tivoxavir marboxil is on clinical hold due to mutagenicity concerns, Traws Pharma is actively addressing these issues to ensure its clinical development plan remains unaffected, demonstrating the company's resilience in navigating regulatory challenges.
- Trial Progress: Traws Pharma has completed enrollment of 90 patients in its Ratutrelvir clinical trial, comparing the drug with Pfizer's Paxlovid, aiming to provide an alternative treatment for patients unable to use Paxlovid.
- Efficacy and Tolerability: Early data analysis indicates that Ratutrelvir has a favorable tolerability profile, faster symptom resolution, and no observed viral rebound events, supporting its potential utility in reducing post-acute sequelae of SARS-CoV-2 infection (Long COVID).
- Influenza Treatment Update: Traws is also advancing Tivoxavir Marboxil as a potential once-monthly oral preventive treatment for seasonal flu, further expanding its pipeline targeting respiratory viral diseases.
- Market Reaction: Although TRAW shares slipped after the opening bell, they gained about 5% in premarket trading, reflecting investor optimism regarding the company's research progress, with the stock rebounding over 115% in 2026.
- Clinical Trial Results: Traws Pharma's ratutrelvir shows fewer adverse events and no viral rebounds in a 90-patient Phase 2 study compared to PAXLOVID®, indicating its potential advantages in treating COVID-19, especially for patients ineligible for PAXLOVID®.
- Efficacy Improvement: The 600mg daily dose of ratutrelvir over 10 days significantly shortens symptom resolution time and has not shown viral rebound events, potentially offering a more effective treatment option for acute COVID-19 patients and supporting its impact on long-term outcomes.
- New Influenza Prevention Approach: Traws Pharma's tivoxavir marboxil is predicted to provide 28-day protection against influenza, with the new compressed tablet formulation showing over 3X effective blood levels in prior studies, potentially offering an innovative prophylactic treatment for seasonal influenza.
- Future Research Plans: The company plans to conduct an influenza prophylaxis challenge study in June 2026, and if results are positive, will advance tivoxavir marboxil into registration studies, further expanding its application potential in the antiviral market.
- Financing Update: Plus Therapeutics announced the pricing of 39,473,684 units at $0.38 each, expecting to raise approximately $15 million, which will provide fresh capital to advance its precision diagnostics and radiopharmaceutical programs targeting central nervous system cancers.
- Market Performance: Connect Biopharma's stock rose 5.96% to $2.31 without any new news, reflecting ongoing investor interest in its lead candidate rademikibart's new mechanism of action data and strategic priorities for 2026.
- Sector Momentum: ABVC BioPharma's shares increased by 3.37% to $2.15, suggesting that investor interest may be driven by broader momentum in the biotech sector despite the absence of new corporate updates.
- Clinical Progress: Traws Pharma's stock rose 2.82% to $1.82 following its announcement of filing a U.S. IND application for tivoxavir marboxil, further supporting investor optimism around the company's pipeline.
Interim Data Release: Traws Pharma Inc. announced interim results from a Phase 2 trial of ratutrelvir, an oral protease inhibitor for mild-to-moderate COVID-19, showing a differentiated clinical profile compared to Pfizer's Paxlovid.
Efficacy and Safety: The analysis indicated that patients treated with ratutrelvir experienced symptom alleviation comparable to those on Paxlovid, with no observed viral rebound events in the ratutrelvir group and fewer adverse events reported.
Patient Cohorts: Among the 37 patients analyzed, 25 received ratutrelvir, while 12 were treated with Paxlovid; notably, 16.2% of ratutrelvir patients were ineligible for Paxlovid due to contraindications.
Strategic Implications: Traws Pharma's Chief Medical Officer highlighted the potential of ratutrelvir in reducing long COVID symptoms, supported by early symptom improvement and favorable tolerability observed in the trial.

- Clinical Data Preliminary Analysis: Traws Pharma's Ratutrelvir demonstrated comparable symptom alleviation time in a clinical trial with 25 out of 37 patients treated, indicating its potential applicability across a broader patient population compared to PAXLOVID™.
- Tolerability Advantage: Ratutrelvir exhibited superior tolerability with only 7.6% of patients reporting mild dyspepsia, while 30% of PAXLOVID™ patients experienced various adverse events, highlighting Ratutrelvir's safety profile in clinical applications.
- No Viral Rebound Events: No viral rebound events were observed in the Ratutrelvir treatment group, whereas 8.3% of PAXLOVID™ patients experienced rebound, further supporting Ratutrelvir's potential advantages in COVID-19 treatment.
- Broad Market Potential: The development of Ratutrelvir targets patients ineligible for PAXLOVID™ therapy, and its favorable tolerability and absence of viral rebound may position it significantly in the future COVID-19 treatment market.








