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  • 24 January 2017
    Arsanis Announces First Patient Dosed in Global Phase 2 Study of ASN100 for Prevention of Staphylococcus Aureus Pneumonia

    Study to evaluate safety and efficacy of ASN100 in high-risk, mechanically ventilated ICU patients.

    WALTHAM, Mass. and VIENNA, Austria – January 24, 2017 – 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 first patient was dosed in a Phase 2 clinical study of its lead program, ASN100. 

    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 (mAbs), ASN-1 and ASN-2, uniquely disarms S. aureus by broadly neutralizing the six cytotoxins key to the pathogenesis of pneumonia. 

    “The Phase 2 trial initiation follows a recently completed Phase 1 safety, tolerability and pharmacokinetic study of ASN100 in healthy volunteers in which data demonstrated half-lives for both ASN-1 and ASN-2 of at least 3 weeks, penetration of both ASN-1 and ASN-2 into bronchial alveolar lavage fluid out to 30 days, and a safety profile that is consistent with fully human monoclonal antibodies,” said Chris Stevens M.D., chief medical officer at Arsanis Inc. “S. aureus pneumonia is an increasing public health threat with a surprising mortality rate despite available antibiotic therapies. Therefore, preventative approaches with monoclonal antibody products that neutralize the virulence of S. aureus are ideally suited for patients at high risk for S. aureus pneumonia.” 

    In the Phase 2 study, mechanically ventilated patients at high risk for S. aureus pneumonia will be randomized 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.   

    “We believe targeted, precision monoclonal antibody therapies are advantageous for the prevention and treatment of infectious diseases while avoiding antibiotic resistance. ASN100 aligns with the medical and scientific field’s desire and need to move from broad-spectrum antibiotics toward prevention in patients that are at high risk of developing infection,” said Rene Russo, Pharm.D., BCPS, chief executive officer, Arsanis. “Initiating the ASN100 Phase 2 study brings us closer to potentially providing this targeted solution for patients who are especially vulnerable to developing S. aureus pneumonia.”