Bio-pharmaceutical company Arsanis has begun dosing patients in a Phase II clinical trial of ASN100 to treat Staphylococcus aureus (S.aureus) pneumonia in high-risk, mechanically ventilated patients.
ASN100 is developed with a combination of two fully human monoclonal antibodies ASN-1 and ASN-2, to neutralise six S. aureus cytotoxins associated with pneumonia pathogenesis.
The Phase II study will evaluate the mechanically ventilated patients at high risk for S. aureus pneumonia for up to 21 days after dosing.
The patients will be randomised to receive a single dose of ASN100 or placebo and up to 350 individuals will be enrolled across 60 sites.
Arsanis chief executive officer Rene Russo said: “We believe targeted, precision monoclonal antibody therapies are advantageous for the prevention and treatment of infectious diseases while avoiding antibiotic resistance.
"ASN100 aligns with the medical and scientific field’s desire and needs to move from broad-spectrum antibiotics toward prevention in patients that are at high risk of developing infection.
“Initiating the ASN100 Phase 2 study brings us closer to potentially providing this targeted solution for patients who are especially vulnerable to developing S. aureus pneumonia.”
ASN-1 is designed to neutralise S. aureus toxin alpha-hemolysin (Hla) along with four leukocidins of the bacteria, which disintegrate human phagocytic (immune) cells.
ASN-2 inactivates leukocidin LukGH, which causes lysis of human phagocytes.
The firm claimed that the completed Phase I study evaluated tolerability and pharmacokinetics of the drug in healthy volunteers and the safety profile was found to be consistent with fully human monoclonal antibodies.
Image: Scanning electron micrograph of Staphylococcus aureus bacteria. Photo: courtesy of Janice Haney Carr/Wikipedia.