BSSL (bile-salt-stimulated lipase) is an important lipase for premature infants, present in fresh mother´s milk, and improving digestion and absorption of essential fatty acids, such as LCPUFAs (long-chain poly-unsaturated fatty acids), critical for the developing brain.
Growth in preterm infants is often inadequate despite efforts to optimize the nutrition. One of the key issues in the treatment of preterm infants with low birth weight is the need for improvement in uptake of energy and fatty acids essential for a normal growth and development. Preterm infants with low birth weight who catch up normal growth in the first year of life are more likely to have optimal outcomes in health, growth and development status throughout childhood.
Kiobrina® is a recombinant human bile-salt-stimulated lipase (rhBSSL) developed by Sobi for enzyme replacement therapy to improve growth and development in preterm infants receiving pasteurized breast milk and/or formula. The rationale for substitution of rhBSSL in 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.
Kiobrina® news
On August 2, 2011 - Sobi announced that the first patient has been enrolled in the phase III study with Kiobrina® (rhBSSL) which is designed to evaluate efficacy, safety and tolerability of Kiobrina® in the treatment of preterm infants. The phase III study is a multicenter, double- blind, placebo-controlled study where preterm infants younger than 32 weeks of gestational age are randomized to receive rhBSSL or placebo added to preterm formula or pasteurized human milk for 4 weeks to demonstrate improved growth velocity. After treatment, there is a follow up period of 1 year. The trial is expected to enroll patients in 70 centers in 11 European countries.