Traws Pharma Completes Analysis of Ratutrelvir Clinical Study in PAXLOVID®-Eligible and Ineligible COVID-19 Patients and Provides Updates for Additional Indication for Tivoxavir Marboxil as a Prophylactic Treatment for Seasonal Influenza

Core Insights - Traws Pharma has completed a clinical analysis of ratutrelvir, showing it has a differentiated profile compared to PAXLOVID® with fewer adverse events and no viral rebounds, while achieving equivalent time to sustained symptom resolution [1][4] - The company is also advancing tivoxavir marboxil, which has shown increased exposure in pre-clinical studies and is being developed as a once-monthly oral tablet for influenza prevention [5][7] Ratutrelvir Update - The Phase 2 study of ratutrelvir involved 90 patients and compared its efficacy and safety against PAXLOVID®, with a specific focus on patients ineligible for ritonavir-boosted therapies [2][3] - Patients receiving ratutrelvir reported fewer treatment-related adverse events (10% vs. 23.3% for PAXLOVID®) and quicker symptom resolution [3] Clinical Benefits of Ratutrelvir - Ratutrelvir may provide significant benefits for a broader range of patients, particularly those unable to receive ritonavir-boosted therapy, with a favorable tolerability profile and absence of viral rebound events [4] - The drug's potential to reduce post-acute sequelae of SARS-CoV-2 infection (Long COVID) is highlighted, suggesting it may enable earlier and more complete viral clearance [4] Tivoxavir Marboxil Update - Traws Pharma is progressing tivoxavir marboxil as a potential best-in-class CAP-dependent endonuclease inhibitor for seasonal influenza, with a single oral tablet formulation showing a 30% increase in exposure compared to previous formulations [5][7] - The company plans to conduct a healthy volunteer study in Australia to confirm the extended exposure and potentially advance to a Seasonal Human Influenza Virus Prophylaxis Challenge Study [7] Regulatory Considerations - The FDA has placed the US IND for tivoxavir marboxil on clinical hold due to concerns regarding mutagenicity data, with formal communication expected by March 16, 2026 [8] - Despite the clinical hold, ongoing and planned studies outside the United States are not directly impacted, and the company is working to address the FDA's concerns [8]