New Clinical Trials To Test Monoclonal Antibodies for Prevention of Widespread Bacterial Infections

The Antibacterial Resistance Leadership Group (ARLG) is working to enroll patients in clinical trials of 2 investigational monoclonal antibodies, with the ultimate goal of reducing the outcomes of antimicrobial resistance.

MEDI3902, an investigational medicine developed by MedImmune, is being assessed in a clinical trial called EVADE, which will determine its safety and effectiveness at preventing pneumonia caused by Pseudomonas aeruginosa (P. aeruginosa) Another investigational medicine, survatoxumab (previously known as MEDI4893) is being evaluated in the SAATELLITE trial which will determine its safety and effectiveness at preventing disease caused by Staphylococcus aureus (S. aureus). Both investigational medicines are monoclonal antibodies that would be utilized alongside antibiotics. In the past, monoclonal antibodies have been used to aid in the treatment for other diseases such as cancer, but they have rarely been used to treat bacterial pathogens.

Researchers are experimenting with monoclonal antibodies on these particular infections because the World Health Organization has listed both P. aeruginosa and S. aureus as becoming increasingly drug-resistant with serious risk to human health. Additionally, the Centers for Disease Control and Prevention has cited Staphylococcus bacteria as a serious threat in health care related-infections. P. aeruginosa, in particular, can cause potentially fatal bloodstream infections and pneumonia, and accounts for more than 400 deaths annually.

“It is becoming increasingly common for hospitalized patients—especially those with weakened immune systems—to develop severe, hard-to-treat bacterial infections,” said National Institute of Allergy and Infectious Diseases Director, Anthony S. Fauci, MD, in a press release, “These clinical trials testing monoclonal antibodies as novel preventive therapies are part of a global collaborative effort to explore innovative ways to mitigate the threat of antimicrobial resistance.”

The participants in both double-blind trials will be placed in intensive care units during the investigation. In the EVADE trial, participants must show signs of P. aeruginosa without the presence of pneumonia. Patients will either receive an infusion of MEDI3902 or a placebo and will be assessed for traces of pneumonia for up to 49 days following the infusion.

SAATELLITE participants must show signs of S. aureus with no traces of related diseases. Similarly, the participants will receive an infusion of survatoxumab or a placebo and will be assessed for pneumonia for 30 days and monitored completely for 190 days.

Patients in both clinical trials will be monitored daily.

Duke University was given a grant by the National Institute of Allergy and Infectious Diseases to support domestic trials, while international trials are being supported by MedImmune and Innovative Medicines Initiative Joint Undertaking and the Combatting Antimicrobial Resistance in Europe (COMACTE) consortium. In total, investigators are attempting to enroll 30 patients from various intensive care units.