BioCentury
ARTICLE | Clinical News

Swedish Orphan falls on Phase III miss for Kiobrina

March 27, 2014 12:34 AM UTC

Swedish Orphan Biovitrum AB (SSE:SOBI) said Kiobrina added to preterm formula or pasteurized breast milk missed the primary endpoint vs. placebo added to preterm formula or pasteurized breast milk in the Phase III LAIF trial to treat fat malabsorption in premature infants. Kiobrina added to formula or breast milk did not improve mean growth velocity from baseline to week four vs. placebo added to formula or breast milk (p=0.49). Kiobrina also missed the secondary endpoints of improving head circumference (p=0.66) and readiness for hospital discharge (p=0.93) vs. placebo. The double-blind, European trial enrolled 410 preterm infants less than 32 weeks of gestational age.

Based on the results, Swedish Orphan said it will not start a U.S. Phase III trial of Kiobrina in the indication; the trial was slated to start in 2Q14. The company expects additional data from the LAIF trial by year end and said a decision regarding next steps for Kiobrina will be made once all of the data are analyzed. Kiobrina is a recombinant human bile salt-stimulated lipase (rhBSSL). ...