Arsanis has announced that the Food and Drug Administration (FDA) has granted Fast Track designation to ASN100, a novel combination of two fully human monoclonal antibodies to potentially prevent Staphylococcus aureus pneumonia.

ASN100 is specifically intended for mechanically ventilated patients who are at high risk for S. aureus pneumonia. The antibodies collectively neutralize six important S. aureus cytotoxins tied to pneumonia pathogenesis.

The ASN-1 antibody neutralizes alphahemolysin (Hla), a key S. aureus toxin responsible for lung epithelial cell damage, in addition to four  S. aureus leukocidins responsible for lysis of human phagocytic cells. The ASN-2 antibody inactivates the remaining S. aureus leukocidin, LukGH, which is a particularly potent human cytotoxin, also responsible for lysis of human phagocytes. 

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A Phase 1 study of ASN100 was recently completed and Arsanis plan to begin dosing in patients in a Phase 2 study before the end of 2016.

“Despite current antibiotic treatments, S. aureus pneumonia has a mortality rate as high as 30 percent in this patient population [Kollef M. “Epidemiology and Outcomes of Health-Care-Associated Pneumonia.” CHEST. 2005 Dec;128(6):3854-62.],” said René Russo, PharmD, BCPS, CEO of Arsanis.

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