Santarus and Pharming announced initiation of their Phase 3b study of RHUCIN (recombinant human C1 inhibitor) for the treatment of acute attacks of angioedema in patients with hereditary angioedema. HAE is a genetic disorder in which the patient is deficient in or lacks a functional plasma protein C1 inhibitor, resulting in unpredictable and debilitating episodes of intense swelling of the extremities, face, trunk, genitals, abdomen and upper airway.
This trial is an international, multicenter, randomized, placebo-controlled clinical study. Pharming expects to enroll approximately 50 patients in the study, which may provide additional data if required by the FDA, in support of an approval for RHUCIN at the 50 U/kg dose. Data from the study will also be used to provide additional validation of the visual analog scale used in measuring the clinical effects of RHUCIN.
RHUCIN is a recombinant version of the human protein C1 inhibitor (C1INH).