SAATELLITE Study Achieves Stage 1 Database Lock

COMBACTE-NET’s SAATELLITE team is very pleased to announce that on the 14^th of September the stage 1 database lock was achieved.

The database was locked following data reconciliation and blinded review of all randomized patients by the adjudication committee, which assessed incidence of pneumonia through 30 days post dose. This important milestone also marks the start of the stage 1 statistical analysis.

Enrollment into the SAATELLITE study had been terminated on the 1^st of April. A total of 767 subjects were screened into the study of which 213 had been randomized.

Following the database lock, the long-term follow-up of the last randomized patients continues and close-out visits are being planned. The study team would like to take the opportunity to thank the sites for their continued efforts throughout the last four years to get to this result. SAATELLITE is the largest pre-emptive approach study to date, and would have been impossible without the hard work at the investigator sites.

SAATELLITE (Human Monoclonal Antibody Against Staphylococcus aureus Alpha Toxin in Mechanically Ventilated Adult Subjects) is a Phase II, randomized, double-blind, placebo-controlled trial. Involving patients who are at high risk of developing ventilator-associated pneumonia in an intensive-care unit. The trial will test the safety, the pharmacokinetic and pharmacodynamic characteristics, and the efficacy of MEDI4893. A novel treatment that uses antibodies against S. aureus.