Pharming Group N.V. announced the successful completion of patient enrolment in the Phase 2 clinical study of RUCONEST(R) (recombinant C1 esterase Inhibitor, 50 IU/kg), for prophylaxis in patients with hereditary angioedema (HAE). Thirty HAE patients deficient in C1 esterase Inhibitor and with a history of at least four attacks per month have been enrolled in the randomized, double-blind study. The patients receive RUCONEST(R) either once or twice weekly, or placebo in each of three four-week treatment periods.

With the crossover design, all patients will receive each of the dosing regimens. The study will evaluate the safety and efficacy of RUCONEST(R) when used for prophylaxis of angioedema attacks in patients with HAE. The recruitment phase of the study was initiated in January 2015 and is being conducted at sites in Canada, Europe, Israel and the United States.

RUCONEST(R) has been granted Orphan Drug designation by FDA for the prophylactic treatment of angioedema caused by hereditary or acquired C1 esterase inhibitor deficiency, with data exclusivity until 2026 under the Biologics Price Competition and Innovation Act.