Traws Pharma announced multiple regulatory submissions

Traws Pharma (TRAW) announced multiple regulatory submissions related to its antiviral pipeline. A proposed Phase 2 dose-ranging, non-inferiority study will evaluate the effects of tivoxavir marboxil, a potential best in class CAP-dependent endonuclease inhibitor, compared to XOFLUZA, in patients infected with seasonal influenza. A separate single arm will evaluate the effects of TXM in patients infected with H5N1 bird flu. The proposed study has been submitted for Human Research Ethics Committee review and is expected to enroll subjects in Australia and selected countries in Southeast Asia with high rates of human bird flu infections. Also, as a follow up to recent Pre-IND FDA interactions on TXM, Traws submitted briefing materials for a Type D meeting to enable further FDA dialog on a potential path to accelerated approval for bird flu. A proposed Phase 2 non-inferiority study will evaluate the effects of ratutrelvir, a potential best in class protease inhibitor that does not require ritonavir co-administration, compared to PAXLOVID, in newly diagnosed COVID patients. The proposed study that has been submitted for HREC review is intended to enroll patients on a 10-day treatment regimen for ratutrelvir compared to the approved 5-day regimen for PAXLOVID. In addition to efficacy and safety endpoints, the proposed study will also evaluate the rates of disease rebound as well as the incidence of Long COVID. A separate single arm will evaluate the safety and efficacy of ratutrelvir in newly diagnosed COVID patients who are ineligible for treatment with PAXLOVID.