Theriva Biologics announces primary endpoints for efficacy met in VIRAGE study

Theriva Biologics (TOVX) announced positive topline outcomes from the VIRAGE Phase 2b clinical trial evaluating the Company’s lead product candidate VCN-01 plus standard-of-care chemotherapy gemcitabine/nab-paclitaxel as a first line therapy for patients with metastatic pancreatic ductal adenocarcinoma for whom gemcitabine/nab-paclitaxel is the recommended first-line treatment option. The analysis of the VIRAGE trial includes data for first-line treatment of 96 newly-diagnosed metastatic PDAC patients: In the primary endpoint analysis, the 48 patients treated with at least one dose of gemcitabine/nab-paclitaxel SoC had a median overall survival of 8.6 months, while the 48 patients treated with VCN-01 followed by at least one dose of gemcitabine/nab-paclitaxel SoC had a median OS of 10.8 months. The improvements in OS in the VCN-01+SoC treatment arm compared to the SoC control arm were reflected in increased progression free survival. The median duration of response was 5.4 months in the SoC control arm, while the median DoR in the VCN-01+SoC treatment arm was doubled to 11.2 months.