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news.Swedish Orphan Biovitrum, encouraged by positive results from Kiobrina clinical phase II study that demonstrated an improvement in preterm infant growth velocity when Kiobrina was administered in pasteurised breast milk, has decided to move Kiobrina into Phase III development.
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Kiobrina is a recombinant human bile-salt-stimulated lipase (rhBSSL) developed to improve growth and development in preterm infants receiving pasteurized breast milk and/or infant formula. The rationale for adding rhBSSL to pasteurized breast milk or infant formula is to restore the natural lipase activity level that is either lost on pasteurization or totally absent in formula.
The phase II Kiobrina program was designed as two parallel prospective randomized double-blind crossover studies where Kiobrina, or placebo, was administered in pasteurized milk, or preterm infant formula, during one week of treatment. All infants were born before week 32 of gestational age. The objectives were to study the lipid absorption, growth velocity, safety and tolerability.
The combined results of the two clinical studies showed an increase in growth velocity, which is a medically relevant parameter. The safety profile was comparable to that of placebo and no drug-related serious adverse events were reported.
The results from these studies are expected to be published during 2010, starting with a presentation of the results from the first clinical study with infant formula at ‘The Power of Programming 2010 International conference on developmental origins of health and disease’ in Munich, Germany on May 6-8, 2010.
Peter Edman, CSO of Swedish Orphan Biovitrum Group, said: “Kiobrina holds a great opportunity to fill a substantial medical need in neonatal care. The result from our Phase II program is an important step towards a valuable product that will support preterm infants in their growth and development.”
Martin Nicklasson, CEO of Swedish Orphan Biovitrum Group, said: “This is yet another exciting late stage development progress for Swedish Orphan Biovitrum with a potential of creating a medical value in neonatal care as well as business growth for our company.”