First Patient Dosed in Arsanis Phase 2 Study of ASN100 for Prevention of Staphylococcus Aureus Pneumonia.
M2 PHARMA-January 25, 2017-First Patient Dosed in Arsanis Phase 2 Study of ASN100 for Prevention of Staphylococcus Aureus Pneumonia
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- The first patient was dosed in a Phase 2 clinical study of US-based biopharmaceutical company Arsanis, Inc.'s lead programme, ASN100, the company said.
The primary objective of this study is to evaluate the safety, tolerability, and efficacy of a single dose of ASN100 versus placebo for the prevention of Staphylococcus aureus pneumonia in high-risk, mechanically ventilated patients.
S. aureus causes serious and life-threatening infections, including pneumonia and bacteremia, and the incidence of healthcare-related S. aureus pneumonia among hospitalized patients is increasing.
Patients in the ICU receiving mechanical ventilation are at increased risk for S. aureus pneumonia, which has an overall mortality rate of approximately 30% in these patients despite antibiotic treatment.
ASN100, a combination of two human monoclonal antibodies, ASN-1 and ASN-2, uniquely disarms S. aureus by broadly neutralising the six cytotoxins key to the pathogenesis of pneumonia.
In the Phase 2 study, mechanically ventilated patients at high risk for S. aureus pneumonia will be randomised to receive a single dose of ASN100 or placebo.
Patients will be evaluated for the development of pneumonia for up to 21 days after dosing. Arsanis plans to enroll approximately 350 patients across 60 sites around the world, including the United States and Europe.
ASN100 is a combination of two fully human monoclonal antibodies that collectively neutralize six important S. aureus cytotoxins associated with pneumonia pathogenesis.
ASN-1 neutralises alpha-hemolysin, 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: Panton-Valentine leukocidin, leukocidin ED, and gamma-hemolysins AB and CB.
ASN-2 inactivates another S. aureusleukocidin, LukGH, which is a particularly potent human cytotoxin that is also responsible for lysis of human phagocytes.
ASN100 is being evaluated in a Phase 2 clinical study for the prevention of S. aureus pneumonia in high-risk patients, and has received Fast Track designation from the US FDA.
Arsanis is a clinical-stage biotechnology company in the development of targeted monoclonal antibodies for pre-emptive therapy and treatment of serious infectious diseases.
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|Date:||Jan 25, 2017|
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