FDA Grants Fast Track Designation to Drug in Preventing S aureus Pneumonia

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.¹

ASN100 is specifically intended for mechanically ventilated patients who are at high risk for S aureus pneumonia. The antibodies collectively neutralize 6 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 4 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.

A Phase 1 study of ASN100 was recently completed and Arsanis plans 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,” said René Russo, PharmD, BCPS, CEO of Arsanis.²

References

1. ASN100: augmenting immune defenses and disarming Staphylococcus aureus. Arsanis, Inc. http://www.arsanis.com/s-aureus/  Accessed December 2, 2016.
2. Kollef MH, Shorr A, Tabak YP, Gupta V, Liu LZ, Johannes RS. Epidemiology and outcomes of health-care-associated pneumonia: results from a large US database of culture-positive pneumonia. Chest. 2005;128:3854-3862.

This article originally appeared on MPR