TRAW News & Events

Traws Pharma announced the completion of the clinical analysis of its 90-patient, open-label Phase 2 study of ratutrelvir, an investigational oral, ritonavir-free Mpro/3CL protease inhibitor, versus Paxlovid in patients with mild-to-moderate COVID-19, together with a single arm in Paxlovid -ineligible subjects. Patients ineligible to receive Paxlovid are frequently at elevated risk for severe disease and require suitable, safe and effective treatment options. Ratutrelvir has the potential to address this gap in care and may be a valuable therapeutic option. Completed clinical results with ratutrelvir confirm a differentiated profile versus Paxlovid with fewer adverse events and no viral rebounds with equivalent time to sustained symptom resolution; results were recapitulated in Paxlovid -ineligible patients, representing a significant population with no effective treatment options. Pre-clinical analysis of tivoxavir marboxil tablets demonstrated significantly increased exposure compared to a prototype formulation with predicted 28-day protection in humans from influenza infections against a wide range of seasonal and pandemic variants. PK study of compressed tivoxavir marboxil tablets submitted under open IND in Australia and preparations are underway for a Human Influenza Prophylaxis Challenge Study in the UK

Traws Pharma announced the completion of enrollment in its ongoing 90-patient, open-label Phase 2 study of ratutrelvir, an investigational oral, ritonavir-free Mpro/3CL protease inhibitor, versus PAXLOVID, in patients with mild-to-moderate COVID-19, together with a single arm in PAXLOVID-ineligible subjects. Patients ineligible to receive PAXLOVID are frequently at elevated risk for severe disease and require suitable, safe and effective treatment options. Ratutrelvir has the potential to address this gap in care and may be a valuable therapeutic option. The Company also provided an update on the progress of the tivoxavir marboxil program for influenza.

Traws Pharma announced the filing of a U.S. IND application with the U.S. Food and Drug Administration, FDA, for tivoxavir marboxil, TXM, a CAP-dependent endonuclease inhibitor as a single oral tablet administered for the treatment of influenza. "This filing represents an important step towards formal consideration of TXM for influenza therapy and inclusion in the strategic national stockpile," commented C. David Pauza, PhD, Chief Scientific Officer of Traws Pharma. "Coupled with our ongoing positive interactions with the U.S. Department of Health and Human Services regarding the unique properties of TXM as a broad pan-influenza strain therapeutic, we remain optimistic about the potential inclusion of this agent in the nation's armamentarium against potential future disease outbreaks."