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# Fast Track for Staph Aureus Pneumonia Therapy
- URL: https://www.fdaweb.com/fast-track-for-staph-aureus-pneumonia-therapy/
- Published: 2016-12-01T12:00:00.000Z
- Updated: 2026-09-14T21:51:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137469

FDA has granted Arsanis fast track status for ASN100 for preventing *Staphylococcus aureus* pneumonia in mechanically ventilated patients who are at high risk for the condition. “Despite current antibiotic treatments, *S. aureus* pneumonia has a mortality rate as high as 30% in this patient population, according to the company.

ASN100 is a combination of two fully human monoclonal antibodies that collectively neutralize six *S. aureus* cytotoxins associated with pneumonia pathogenesis. ASN-1 neutralizes alphahemolysin, a key *S. aureus* toxin responsible for lung epithelial cell damage, in addition to four *S.aureus* leukocidins responsible for lysis of human phagocytic (immune) cells, the company says. ASN-2 inactivates the remaining *S.aureus* leukocidin, LukGH, which is a potent human cytotoxin that is also responsible for lysis of human phagocytes.

Arsanis has recently completed a Phase 1 clinical study of ASN100, and plans to begin dosing patients in a Phase 2 study later this year.