Sobi Announces First Patient Enrolled in Kiobrina Study

Swedish pharmaceutical company Sobi has recruited first patient in Kiobrina Phase III trial.

Stockholm-based pharmaceutical company Swedish Orphan Biovitrum (Sobi) has enrolled the first patient in a Phase III trial to evaluate the safety, tolerability and efficacy of its Kiobrina medication in the treatment of pre-term infants. The Phase III study is expected to enrol patients in 70 centres across 11 European countries.

Kiobrina is a recombinant produced human bile-salt stimulated lipase (rhBSSL) to improve growth in pre-term infants who receive pasteurised breast milk or infant formula.

In the multicentre, double-blind, placebo-controlled trial, preterm infants younger than 32 weeks of gestational age will be randomised to receive rhBSSL or a placebo added to pre-term formula or pasteurised human milk for four weeks to demonstrate improved growth velocity.