Traws Pharma Files Tivoxavir Marboxil Investigational New Drug (IND) Application for Influenza Therapy, and Provides Updated Results from the Ongoing Clinical Study of Ratutrelvir in PAXLOVID®-Eligible and Ineligible COVID-19 Patients

Core Insights - Traws Pharma has filed a U.S. IND application for tivoxavir marboxil (TXM), a potential treatment for influenza, marking a significant step towards its inclusion in the strategic national stockpile [1][3][4] - Updated clinical results for ratutrelvir indicate a favorable profile compared to PAXLOVID, with fewer adverse events, no viral rebounds, and quicker symptom resolution, particularly in patients ineligible for PAXLOVID [1][5][8] Company Developments - Traws Pharma is a clinical-stage biopharmaceutical company focused on developing therapies for respiratory viral diseases, including COVID-19 and influenza [18] - The company is advancing ratutrelvir as a ritonavir-independent treatment for COVID-19, targeting the Main protease (Mpro or 3CL protease) [18] - Traws Pharma is also developing tivoxavir marboxil as a single-dose treatment for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease [18] Clinical Study Insights - The ongoing Phase 2 study of ratutrelvir has enrolled 50 patients, with 95% of the planned 90-patient population already enrolled [6] - Interim analysis shows that ratutrelvir-treated patients had a time to sustained symptom resolution of 12 days compared to 14 days for PAXLOVID-treated patients (p<0.014) [8][9] - Ratutrelvir demonstrated a better safety profile, with only 7.6% of patients reporting mild dyspepsia, while 30% of PAXLOVID patients reported adverse events [11][12] Market Potential - The seasonal influenza market represents a multi-billion dollar opportunity, driven by global health organizations and government initiatives [15] - The COVID-19 treatment market also presents significant potential, with ratutrelvir positioned as a next-generation oral 3CL protease inhibitor [14][15]