Biopharmaceutical company Santarus and biotech specialist Pharming have announced the start of a Phase IIIb clinical study evaluating RHUCIN (recombinant human C1 inhibitor) for the treatment of acute attacks of angiooedema in patients with hereditary angiooedema.
The study is designed to provide additional data, if required, by the US Food and Drug Administration (FDA) for the approval of RHUCIN at the 50U/kg dose.
Data from the study will also be used to provide additional validation of the visual analogue scale used in measuring the clinical effects of RHUCIN.
The international, multicentre, randomised, placebo-controlled Phase IIIb clinical study will enrol approximately 50 patients.
The safety and efficacy of RHUCIN for the treatment of hereditary angiooedema attacks has been previously assessed in two randomised placebo-controlled studies and four open label treatment studies.
The two placebo-controlled clinical studies showed statistically significant and clinically relevant improvement in the primary endpoint which was defined as of time to beginning of relief of symptoms compared to placebo.
In October 2010, Pharming received marketing authorisation in the European Union for RUCONEST (RHUCIN in non-European territories) for the treatment of acute angiooedema attacks in patients with hereditary angiooedema.
Santarus has licensed certain exclusive rights from Pharming to commercialise RHUCIN in North America for the treatment of acute attacks of hereditary angiooedema and other future indications.