C1-INH Reaches Primary Endpoint in Phase III Trial

CSL Behring’s human pasteurized C1-inhibitor (C1-INH) concentrate reached its primary endpoint in a Phase III trial treating patients with hereditary angioedema, a rare genetic disorder that can lead to life-threatening swelling of the face, airway, abdomen and extremities.

The results from the multicenter, double-blind, placebo-controlled IMPACT trial showed patients treated with C1-INH experienced a reduction in time to relief of symptoms compared with placebo, according to CSL Behring.

Results will be submitted shortly to the FDA, Health Canada and European health regulators in support of C1-INH applications. The company has manufactured the product for more than 20 years in several countries, including Germany, Austria and Switzerland, under the name Berinert P.