LAB-Net, based at the University of Antwerp, will play a key role in the Phase 3 SAATELLITE-2 clinical trial. This clinical trial, conducted in collaboration with ARIDIS Pharmaceuticals, aims to provide of the efficacy and safety of suvratoxumab. LAB-Net will assist in site selection process, compiling a laboratory sample collection and management manual and site training on laboratory-related topics.
Bacterial pneumonia occurring within the hospitalized or ICU population is a serious threat that contributes significantly to morbidity and mortality. S. aureus, a major bacterial pathogen, is the primary cause of nosocomial pneumonia. The new Phase 3 SAATELLITE-2 clinical study aims to provide evidence of the efficacy and safety of suvratoxumab (AR-320) for the prevention of nosocomial pneumonia caused by S. aureus in the target population of mechanically ventilated adults and adolescents at high risk of developing S. aureus nosocomial pneumonia. EFPIA Partner ARIDIS Pharmaceuticals will conduct this study in collaboration with the COMBACTE consortium of leading academic, clinical, and microbiological researchers in the field of antibiotic-resistant bacteria and ventilator-associated and ICU pneumonia. The SAATELLITE-2 study will be conducted at approximately 100 European and 100 non-European sites.
Currently, LAB-Net is helping to select sites in and outside Europe. Isolates and biomarker samples collected by study sites will be shipped to LAB-Net, as a Research Laboratory in this study. If you would like to participate in this study or wish to get more information, please contact the LAB-Net team at Combacte.firstname.lastname@example.org.
SAATELLITE-2 is a phase 3, randomized, double-blind, placebo-controlled, single-dosed trial, focusing on human monoclonal antibody against Staphylococcus aureus alpha toxin in mechanically ventilated adult and adolescent subjects. SAATELLITE-2 involves patients who are in an intensive-care unit (ICU) at high risk of developing nosocomial pneumonia caused by S. aureus.
Suvratoxumab is a novel, fully human mAb, being developed to pre-emptively treat high-risk patients to prevent S. aureus pneumonia in the ICU setting. In the Phase 2 SAATELLITE study Suvratoxumab has been shown to exhibit a favorable safety profile, and was associated with a reduction in S. aureus ICU pneumonia and shorter duration of ICU and hospital stays. The upcoming Phase 3 study is designed to confirm the efficacy of suvratoxumab in ICU patients in preventing S. aureus pneumonia.