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Arsanis starts phase 1 study of lead product candidate ASN100

Arsanis announced that the first cohort has been initiated in its Phase 1 clinical trial of ASN100, a novel combination of two monoclonal antibodies that target the pathogen Staphylococcus aureus.

The study is being conducted in Vienna, Austria, and will examine the safety, tolerability, and pharmacokinetics of ASN100 in healthy volunteers.

Arsanis chief development officer Rene Russo said: "This is an exceptional time to be in infectious diseases, and with the start of our ASN100 Phase 1 clinical trial, Arsanis is working to advance precision therapies targeting pathogens of high unmet medical need.

"Unlike other single-target antibody approaches, ASN100 works by neutralizing the six most important S. aureus toxins, thereby protecting tissues from toxin effects and preserving immune cells to combat the infection. It is our hope that extensive clinical testing will demonstrate the potential effectiveness of this innovative, non-antibiotic therapy in the prevention and treatment of S. aureus infections while preserving the host microbiome and mitigating resistance."

S. aureus remains a major global threat, and is a leading cause of healthcare-associated infection, including lower respiratory tract and surgical site infections. In the US, S. aureus’ attributable mortality rates are as high as 50% for certain hospital-acquired infections.

Current antibiotic therapies often fall short of medical need and may cause collateral damage to the patient’s microbiome. In addition, it has become apparent in recent years that pathogenic cytotoxins produced by S. aureus play a significant role in preventing bacterial elimination by the host immune system, and traditional antibiotics do not address these important toxins.

Arsanis co-founder, president, and chief scientific officer Eszter Nagy said: "This is an important milestone for Arsanis and demonstrates our commitment to becoming a leader in the field of novel anti-infective antibodies."

ASN100 was discovered in collaboration with Arsanis’ strategic partner Adimab LLC (Lebanon, NH, US), using its industry-leading antibody discovery platform. The program has been supported by the Austrian Research Promotion Agency (FFG) from conception to clinical testing.