Traws Pharma, Inc.(US:TRAW)2025-04-09 16:45Bird Flu - Tivoxavir marboxil (TXM) - TXM demonstrates a broad resistance profile against avian flu strains, including the "Texas dairy worker strain"[16] - A single dose of TXM provided protection from disease and mortality in three preclinical models[17] - Phase 1 data showed that a single 480 mg dose of TXM maintained plasma blood levels above the EC90 for approximately 3 weeks in healthy volunteers[18, 60] - The company submitted a pre-IND meeting request to the FDA on March 21, 2025, to seek accelerated approval under the Animal Rule[63, 102] - In mice infected with bird flu, TXM provided 100% protection against lethal bird flu challenge[26] - In ferrets infected with bird flu, TXM doses increased survival, with the 240 mg human equivalent dose resulting in 50% survival compared to 0% in the control group[36, 47] - In non-human primates infected with bird flu, a single dose of TXM significantly lowered lung viremia and prevented virus-induced weight loss[50, 51] COVID-19 - Ratutrelvir - Ratutrelvir exhibits a broad resistance profile against native, emerging variants, and treatment-resistant strains compared to nirmatrelvir and ibuzatrelvir[75] - At the recommended Phase 2 dose (RP2D), ratutrelvir maintains favorable pharmacokinetics, with plasma drug levels approximately 13 times the EC50 and high lung accumulation[76] - Phase 1 data indicate that ratutrelvir's drug metabolism is not induced, supporting its ritonavir-independent use[78] - A daily oral 600 mg dose of ratutrelvir sustains drug levels above EC90 for 10 days in healthy volunteers[88] Financials and Outlook - As of December 31, 2024, the company's cash, cash equivalents, and short-term investments totaled $213 million, supporting planned operations into Q1 2026[104]