SOBI’s Kiobrina pivotal Ph III study fails to meet primary endpoint

27 March 2014

Stockholm-based Swedish Orphan Biovitrum (STO: SOBI) has released disappointing top-line results from a Phase III clinical trial of its enzyme therapy Kiobrina (bucelipase-alfa; rhBSSL – recombinant human Bile Salt Stimulated Lipase).

The primary endpoint of the study - growth velocity measured after four weeks of treatment with rhBSSL - was not met. No statistically significant improvement in growth velocity was demonstrated in preterm infants treated with rhBSSL compared to placebo.

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