ST266 in Infants With Necrotizing Enterocolitis (NEC)

• Cohort 1 - lower dose active + SOC treatment vs. SOC alone in higher weight range

  Infants with weight at diagnosis of NEC >=1000 g and <=3000 g; 0.5 mL/kg of ST266, QD, + Standard of Care (SOC) treatment (n=6); SOC (n=3)

• Cohort 2 - higher dose active + SOC treatment vs. SOC alone in higher weight range

  Infants with weight at diagnosis of NEC >=1000 g and <=3000 g; 1.0 mL/kg of ST266, QD; + Standard of Care (SOC) treatment (n=6); SOC (n=3)

• Cohort 3 - lower dose active + SOC treatment vs. SOC alone in lower weight range

  Infants with weight at diagnosis of NEC >=500 g and <=999 g; 0.5 mL/kg of ST266, QD; + Standard of Care (SOC) treatment (n=6); SOC (n=3)

• Cohort 4 - higher dose active + SOC treatment vs. SOC alone in lower weight range

  Infants with weight at diagnosis of NEC >=500 g and <=999 g; 1.0 mL/kg of ST266, QD; + Standard of Care (SOC) treatment (n=6); SOC (n=3)

Primary

• Incidence of adverse eventsFrom date of randomization through 24 months of age

• Incidence of serious adverse eventsFrom date of randomization through 24 months of age

• Changes in labs and vitals relative to disease progressionFrom date of randomization through 24 months of age

Secondary

• Time to pneumatosis resolutionFrom date of NEC diagnosis until resolved, up to 10 days

• Time to full enteral nutrition assessment

• Incidence of abdominal surgical interventionFrom Day 1/Baseline visit through 24 months of age

• Change in Neonatal Sequential Organ Failure Assessment (nSOFA) scoreFrom Randomization/Day 1 through Day 10 of treatment period