- Traws Pharma (TRAW, Financial) advances its antiviral pipeline with multiple Phase 2 protocol submissions for TXM and ratutrelvir.
- The TXM study targets both seasonal and bird flu, with an aim for accelerated approval discussions with the FDA.
- Ratutrelvir will be evaluated against PAXLOVID® in COVID-19 patients, focusing on disease rebound and Long COVID symptoms.
Traws Pharma, Inc. (NASDAQ: TRAW), a clinical-stage biopharmaceutical innovator focused on respiratory viral diseases, has announced significant progress in its antiviral portfolio with the submission of multiple regulatory protocols for two promising drug candidates, tivoxavir marboxil (TXM) and ratutrelvir.
The company has submitted a Phase 2 protocol to the Human Research Ethics Committee (HREC) for TXM, a CAP-dependent endonuclease inhibitor, to assess its efficacy against both seasonal and H5N1 bird flu in the Southern Hemisphere, particularly targeting regions in Australia and Southeast Asia with high bird flu transmission rates. This submission is accompanied by briefing documents to the FDA, seeking a Type D meeting to explore a potential pathway for accelerated approval of TXM for bird flu treatment under the Animal Rule.
In addition to TXM, Traws Pharma is advancing ratutrelvir, a protease inhibitor that operates without the need for ritonavir co-administration. The Phase 2 study protocol submitted to HREC aims to compare ratutrelvir against PAXLOVID® in newly diagnosed COVID-19 patients. This study has extended endpoints to monitor disease rebound and Long COVID development, alongside evaluating ratutrelvir's use in patients ineligible for PAXLOVID® treatment.
Traws Pharma's strategic submissions underscore its commitment to addressing unmet medical needs in antiviral therapies, positioning TXM and ratutrelvir as potential "best in class" treatments in their respective areas. With these studies, the company aims to set a competitive edge in the antiviral market, supported by robust preclinical data and innovative trial designs.
