Kiobrina: Phase III data
Top-line data from the double-blind, European Phase III LAIF study in 410 preterm infants <32 weeks of gestational age showed that Kiobrina added to preterm formula or pasteurized breast milk missed the primary endpoint of improving mean growth velocity from baseline to week 4 vs. placebo added to preterm formula or pasteurized breast milk (16.8 vs. 16.6 g/kg/day, p=0.49). Kiobrina also missed the secondary endpoints of improving head circumference (3.92 vs. 3.88 cm, p=0.66) and readiness for hospital discharge (45.1 vs. 45.2 days, p=0.93) vs. placebo.
In a pre-specified subgroup of infants small for gestational age (n=62), which are infants with a birth weight below the 10th percentile for gestational age, Kiobrina improved mean growth velocity by 17.1 g/kg/day from baseline to week 4 vs. 15.1 g/kg/day placebo. Swedish Orphan said further analysis is required to determine the relevance of the small for gestational age finding. There was a higher incidence of adverse events observed in the Kiobrina arm vs. the placebo arm. In the Kiobrina arm, there were signs of gastrointestinal intolerance and potential cases of necrotizing enterocolitis. ...