Clinical-stage biopharmaceutical company Traws Pharma, Inc. (NASDAQ: TRAW) on Thursday reported final results from a 92-patient Phase 2a study of ratutrelvir, its investigational once-daily oral COVID-19 treatment, and said a bridging study of its influenza candidate tivoxavir marboxil (TXM) met its objectives.
In patients eligible for PAXLOVID, ratutrelvir was found to achieve a median time to sustained symptom resolution of 13.5 days versus 14.5 days for PAXLOVID, with similar declines in viral RNA, no virologic rebound through Day 28, and fewer treatment-related adverse events. Among PAXLOVID-ineligible patients, ratutrelvir produced a similar rate of viral clearance, symptom resolution in 14.0 days, and no treatment-related adverse events.
Traws plans to discuss a registration strategy with the US Food and Drug Administration focused on high-risk adult COVID-19 patients who are ineligible for PAXLOVID, including a potential adaptive Phase 2b/pivotal programme and Fast Track designation.
The company also completed a bridging study of a compressed tablet formulation of TXM, an investigational long-acting influenza prophylactic, which showed comparable exposure to the powder-in-capsule formulation and supported the potential for once-monthly dosing and further efficacy studies.
Traws also completed toxicology retesting for TXM, including two independent rat Pig-a gene mutation studies that found no mutagenic effects at doses up to 500 mg/kg. The company said the results support an updated regulatory submission planned for the fourth quarter of 2026.
Compass Pathways completes FDA application for COMP360 in treatment-resistant depression
bioMérieux secures FDA clearance for updated gastrointestinal diagnostic panels
Photocure maintains 2028 Medicare coverage target for AssureMDx following CMS update
Johnson & Johnson reveals new Phase 2 nipocalimab study data in Sjögren's disease
SK Biopharmaceuticals submits cenobamate supplemental New Drug Application to US FDA
Agilent acquires Proscia for USD240m
BeOne Medicines wins FDA Priority Review for BRUKINSA combination in first-line mantle cell lymphoma
United Therapeutics eliminates Pfizer royalty obligations on ralinepag for USD525m
StimLabs launches DermaForm collagen scaffold particulate device
Merck launches Phase 3 trial of Ohtuvayre for COPD exacerbation prevention
Vivesto secures US orphan drug designation for Cantrixil in acute myeloid leukemia
Lupin's Amifampridine Tablets approved by US FDA
Roche wins FDA clearance for customisable respiratory pathogen test