The randomized, double-blind, placebo-controlled clinical trial (NCT02940626) aims to determine the safety, effectiveness, and tolerability of a single dose of ASN100 vs. a placebo for the prevention of S. aureus pneumonia in 354 heavily colonized and mechanically ventilated subjects.
All patients will be evaluated for the development of pneumonia for up to 21 days after dosing. The study is being conducted across 60 sites around the world, including Europe and 11 sites in the U.S.
In September 2016, Arsanis reported the results of two studies that demonstrated the two human antibodies ASN-1 and ASN-2 that make up ASN100 were able to effectively target S. aureus infections.
A Phase 1 safety, tolerability and pharmacokinetic study of ASN100 in healthy volunteers showed half-lives for both ASN-1 and ASN-2 of at least three weeks and penetration of both antibodies into bronchial alveolar lavage fluid out to 30 days, Chris Stevens, MD, chief medical officer at Arsanis, said in a press release.
“S. aureus pneumonia is an increasing public health threat with a surprising mortality rate despite available antibiotic therapies,” he added. “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.”
S. aureus pneumonia is particularly difficult to treat since the microorganism releases multiple toxins that current antibiotics are unable to neutralize. These toxins damage cells lining the airways and destroy immune cells that are needed to fight the infection, leading to a high mortality rate associated with the disease.
Patients in intensive care units (ICU) under mechanical ventilation are particularly vulnerable to S. aureus pneumonia, which despite antibiotic treatment, is still the cause of 30 percent of deaths among these patients.
“We believe targeted, precision monoclonal antibody therapies are advantageous for the prevention and treatment of infectious diseases while avoiding antibiotic resistance,” said Rene Russo, PharmD, BCPS, CEO of Arsanis. “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.
“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,” Russo added.
More information about the Phase 2 trial and how to participate is available here.