First Patient Enrolled in Phase 3 SAATELLITE-2 Study

Within the study, LAB-Net is responsible for:

• Participating in the site selection process;
• Creating the laboratory “Sample Collection and Management Manual”;
• Conducting site trainings on laboratory-related topics.

LAB-Net has started the site selection process: 76 sites have been selected worldwide. The site selection will continue as we aim to select 200 sites worldwide.

The “Sample Collection and Management Manual” has been also finalized. This manual describes all procedures regarding the samples to be collected for the SAATELLITE-2 study, starting with the collection of the samples, continuing with processing, storage, and finally there is information on the delivery of the materials to the central laboratory.

LAB-Net started training local sites as part of site initiation visits (SIVs). The first training was on August 17. So far, 6 trainings were conducted.

On 30 and 31 August 2022, a Virtual Investigators Meeting of SAATELLITE-2 study took place. During this two-day meeting, the study was explained to the investigators from all selected sites. On the second day, LAB-Net presented the sample collection and management part of the study.

At the end of the study, LAB-Net, as the main research laboratory in this study, will receive the isolates and biomarker samples collected from the sites.

About SAATELLITE-2

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.

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.

About Suvratoxumab

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.