Swedish Orphan Biovitrum announced the results from the second Kiobrina clinical phase-II study. The study demonstrated an improvement in preterm infant growth velocity when Kiobrina was administered in pasteurized breast milk. As a consequence of this outcome and the previously announced positive results from a phase-II study in preterm infant formula, Swedish Orphan Biovitrum has taken the decision to move Kiobrina into phase-III development.
The combined results of the two clinical studies showed a statistically significant increase (p<0.001) 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 will 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 to 8, 2010.
"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," said Peter Edman, CSO of Swedish Orphan Biovitrum Group.
"This is yet another exciting late stage development progress for Swedish Orphan Biovitrum with a potential of creating a unique medical value in neonatal care as well as business growth for our company," said Martin Nicklasson, CEO.
Kiobrina is a recombinant human bile-salt-stimulated lipase (rhBSSL) developed by Swedish Orphan Biovitrum, aiming to improve growth and development in preterm infants receiving pasteurized breast milk and/or infant formula.
Swedish Orphan Biovitrum is a Swedish based specialty pharmaceutical company with an international market presence. The company is focused on providing and developing orphan and niche specialist pharmaceuticals to patients with high medical needs.