Traws Pharma Completes Enrollment of Ratutrelvir Clinical Study in PAXLOVID®-Eligible and Ineligible COVID-19 Patients; Announces Plans for Added Indication for Tivoxavir Marboxil as a Prophylactic Treatment for Seasonal Influenza

Core Insights - Traws Pharma's ongoing clinical results with ratutrelvir indicate a differentiated profile compared to PAXLOVID, showing fewer adverse events, no viral rebounds to date, and faster time to sustained symptom resolution, particularly in PAXLOVID-ineligible patients [1][4][9] - The company is also advancing tivoxavir marboxil, which is predicted to provide 28-day protection against a wide range of seasonal and pandemic influenza variants [1][5][6] Ratutrelvir Update - The Phase 2 study of ratutrelvir is an active-controlled trial against PAXLOVID, focusing on patient-reported outcomes, safety, and usability [2] - Patients in the ratutrelvir arm received 600 mg orally once daily for 10 days, while the comparator arm received PAXLOVID as per approved guidelines [3] - The data suggests ratutrelvir may benefit a broader range of patients, especially those unable to receive ritonavir-boosted therapy, with a favorable tolerability profile and absence of viral rebound events [4] Tivoxavir Marboxil Update - Traws Pharma is progressing tivoxavir marboxil as a single monthly oral tablet for prophylactic treatment of seasonal influenza [5] - Previous Phase 1 studies indicated that a powder-in-capsule formulation provided blood levels exceeding 3X the EC50 for common seasonal influenza variants for up to 22 days [6] - A new compressed tablet formulation is expected to provide 28-day coverage, with a challenge study planned for June 2026 [7] Market Opportunity - The COVID treatment market represents a potential multi-billion dollar opportunity, with ratutrelvir targeting the Main protease (Mpro) of SARS-CoV-2 [9] - Seasonal influenza also represents a significant multi-billion dollar market opportunity, driven by global health organizations and potential pandemic flu outbreaks [10]