Pagibaximab Seems Safe, Well Tolerated in High-Risk Neonates

Three once-a-week infusions of pagibaximab tied to staphylococcal sepsis prevention

MONDAY, July 25 (HealthDay News) -- Three once-a-week infusions of 90 mg/kg of pagibaximab in neonates who are at high risk for staphylococcal sepsis appears to be safe and well tolerated, with no cases of staphylococcal sepsis occurring, according to a study published online July 25 in Pediatrics.

Leonard E. Weisman, M.D., from the Baylor College of Medicine in Houston, and colleagues compared the clinical activity, pharmacokinetics, safety, and tolerability of weekly pagibaximab with that of placebo infusions in 88 very low body weight 2- to 5-day old infants. Infants with a birth weight of 700 g to 1,300 g were randomly assigned to receive three once-a-week infusions of 90 mg/kg (20 subjects) or 60 mg/kg (22) of pagibaximab, or placebo (46). Blood samples were collected for pharmacokinetics, bacterial killing, and safety analyses, and data were collected to track adverse events and clinical outcomes.

The investigators found no difference in demography, mortality, or morbidity between the three groups. Linear pharmacokinetics, a 14.5-day half-life, and nonimmunogenicity were observed for pagibaximab. A total of 0, 20, and 13 percent for patients in the 90 mg/kg, 60 mg/kg, and placebo groups, respectively had definite staphylococcal sepsis, and nonstaphylococcal sepsis occurred in 0, 10, and 15 percent of infants, respectively. The estimated or observed pagibaximab levels were less than 500 µg/mL (target level) in all patients with staphylococcal sepsis.

"No staphylococcal sepsis occurred in infants who received 90 mg/kg. Target levels were only consistently achieved after two to three doses. Dose optimization should enhance protection," the authors write.

All the study authors disclosed financial relationships with Biosynexus Inc., which provided the study drug and funded the study.

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