Pharming and Salix Announce Initiation of Clinical Study of RUCONEST® for Prophylaxis of Hereditary Angioedema
Pharming and Salix Announce Initiation of Clinical Study of RUCONEST® for Prophylaxis of Hereditary Angioedema
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LEIDEN, THE NETHERLANDS, RALEIGH, NC, August 28, 2014 – Pharming Group NV (EURONEXT: PHARM) and Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the initiation of a clinical study of RUCONEST®, (C1 Esterase Inhibitor [Recombinant]) 50 IU/kg, for attack prophylaxis in patients with hereditary angioedema (HAE).
The Phase 2 randomized, double-blind, placebo-controlled, crossover study will evaluate the safety and efficacy of RUCONEST® when used for the prophylaxis of angioedema attacks in patients with HAE. The study will enroll approximately 30 patients and compare a dosing regimen of RUCONEST® given either once or twice weekly versus placebo over a total of 12 weeks. The initiation of the study follows the filing of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA). The study will be conducted at sites in Europe and the United States.
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