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.
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.
The multicentre, double-blind, placebo-controlled Phase III study is expected to enrol patients in 70 centres across 11 European countries.
In the 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.
The combined results from two Phase II studies of Kiobrina showed an increase in growth velocity and uptake of long chain polyunsaturated fatty acids, such as docosahexanoic acid and arachidonic acid (omega-3 and omega-6 fatty acids).