Kiobrina shows positive phase II results in preterm infants

27-Nov-2009 - Sweden

Biovitrum AB announced that the first of two clinical phase II studies, designed to together show proof of concept of Kiobrina(TM) (rhBSSL) in preterm infants, has been completed. The results show statistically significant improvement in the growth velocity in preterm infants when Kiobrina(TM) was added to infant formula compared to placebo. The safety profile was comparable to that of placebo and no drug related serious adverse events were reported.

The study was a prospective randomized double-blind crossover study where Kiobrina(TM), or placebo, was administered in preterm infant formula during one week of treatment. All infants were born before week 32 of gestational age. The next step in the establishment of proof of concept is the completion of the second study where preterm infants are treated with Kiobrina(TM) administrated in pasteurized breast milk. Results from this second trial are expected in the beginning of 2010.

"The initial Phase II clinical results in this high medical need population are very encouraging. If the ongoing parallel study in preterm infants fed with pasteurized breast milk is also positive, we have proof of concept and will advance the program into a registrational stage," said Martin Nicklasson, CEO of Biovitrum.

Kiobrina is a recombinant human bile-salt-stimulated lipase (rhBSSL) developed by Biovitrum 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.

https://www.bionity.com/en/news/110050/kiobrina-shows-positive-phase-ii-results-in-preterm-infants.html