SAATELLITE Results Published in Lancet Infectious Diseases

THE SAATELLITE STUDY

SAATELLITE was a preemptive treatment phase 2 study with the primary endpoint measuring the incidence of Staphylococcus aureus (SA) pneumonia within 30 days post-dose. Study subjects were patients hospitalized in the intensive care unit (ICU), colonized with SA (determined by a rapid point-of-care PCR diagnostic test), that were dosed with either suvratoxumab, a monoclonal antibody (mAb) that neutralizes the SA alpha-toxin (either 2000 mg or 5000 mg IV), or placebo. The 2000 mg suvratoxumab arm was discontinued based on the pre-defined PK criteria by recommendation from the data monitoring committee. Over the course of 4 years, 767 patients were screened and 198 subjects were randomized (196 dosed) into the suvratoxumab 5000 mg and placebo arms. SA pneumonia occurred in 26% in the placebo arm (26 out of 100), compared to 17.7% of suvratoxumab 5000 mg arm patients (17 of 96) for a relative risk reduction (RRR) of 31.9%. Trends suggesting efficacy were also observed for all-cause pneumonia and all-cause-pneumonia or death analyses. Compared to placebo, suvratoxumab was also associated with 3 days shorter hospitalization: 2.4 fewer days in ICU, and 1.2 days less in mechanical ventilation duration. In the two randomization arms, the percentages of patients with at least 1 adverse event and 1 serious adverse event were similar.

The SAATELLITE study results demonstrate the success of a rapid PCR-based enrichment strategy to identify ICU patients colonized with SA in endotracheal aspirates. The strategy worked to identify patients with higher risk of developing a SA pneumonia at a much higher rate than in the general ICU population, which can be of use for future studies. In addition, the SAATELLITE study provided data supporting the potential role of monoclonal antibodies in preventing ventilator-associated pneumonia (VAP) in ICU patients using a preemptive treatment approach.

A SUCCESFUL PARTNERSHIP

The publication of this manuscript is an important milestone within the COMBACTE-NET project demonstrating the synergy that has developed within this successful public-private partnership. The SAATELLITE study is the first interventional trial designed, initiated and completed within the COMBACTE consortium, representing a successful partnership between Academic and EFPIA partners to develop novel medicines for patients in Europe. Throughout each step of the study, there was a great collaboration between the academic partners and AstraZeneca, creating a new collective dynamism in clinical research.