WALTHAM, Mass. & VIENNA--(BUSINESS WIRE)--Arsanis, Inc., a clinical-stage biopharmaceutical company developing targeted monoclonal antibodies (mAbs) for pre-emptive and post-infection treatment of serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ASN100 for the prevention of Staphylococcus aureus pneumonia in mechanically ventilated patients who are at high risk for S. aureus pneumonia.
Fast Track designation is intended to facilitate the development and expedited FDA review of drugs to treat serious or life-threatening conditions and address unmet medical needs.
“Despite current antibiotic treatments, S. aureus pneumonia has a mortality rate as high as 30 percent in this patient population1,” said René Russo, Pharm.D., BCPS, Chief Executive Officer, Arsanis. “We are pleased that the FDA has granted Fast Track designation to ASN100 to prevent S. aureus pneumonia in high-risk, mechanically ventilated patients, and we look forward to working closely with the Agency as we continue the development of our lead monoclonal antibody program for this vulnerable patient population.”
ASN100 is a combination of two fully human monoclonal antibodies that collectively neutralize six important S. aureus cytotoxins associated with pneumonia pathogenesis. ASN-1 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 (immune) cells: the Panton-Valentine leukocidin (PVL), leukocidin ED, and gamma hemolysins AB and CB. ASN-2 inactivates the remaining S. aureus leukocidin, LukGH, which is a particularly 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 in 2016.
About Arsanis, Inc.
Arsanis is a clinical-stage biotechnology company leading the development of targeted monoclonal antibodies (mAbs) for pre-emptive therapy and treatment of serious infectious diseases. The company’s current programs address pathogenic processes selectively, rather than aiming to broadly eliminate bacteria, potentially allowing Arsanis to address critical infections without contributing to the problem of antibiotic resistance. The company is building a broad product pipeline addressing the most important Gram-positive and Gram-negative bacterial pathogens threatening hospitalized and high-risk patients. Its lead clinical program, ASN100, is aimed at serious Staphylococcus aureus infections. Arsanis expects to initiate a Phase 2 study of ASN100 in 2016.
Arsanis is a U.S. company headquartered in Waltham, Massachusetts, with European research and preclinical development operations headquartered in Vienna, Austria (Arsanis Biosciences GmbH). For more information, please visit the Arsanis website at www.arsanis.com.
1Kollef M. “Epidemiology and Outcomes of Health-Care-Associated Pneumonia.” CHEST. 2005 Dec;128(6):3854-62.