LEIDEN, The Netherlands, July 18, 2016 /PRNewswire/ --
RUCONEST(R) showed clinically and statistically significant reduction in attack
frequency both in twice weekly and once- weekly dosing
Pharming Group N.V. ("Pharming" or "the Company") today announced positive results from a Phase 2 clinical study of RUCONEST(R) (recombinant C1 esterase inhibitor, 50 IU/kg) for prophylaxis in patients with hereditary angioedema (HAE). In the study, RUCONEST(R) showed a clinically relevant and statistically significant reduction in attack frequency for both the twice-weekly and once-weekly treatment regimens as compared with placebo.
Thirty-two HAE patients deficient in C1 esterase inhibitor and with a history of at least four attacks per month were enrolled in the randomized, double-blind, placebo-controlled study. The patients received RUCONEST(R) once and twice weekly and placebo in each of three four-week treatment periods in a cross-over design. The primary efficacy endpoint was the number of HAE attacks per 28 day treatment period and the secondary endpoint was clinical response, defined as a greater than or equal to 50% reduction in the number of attacks from treatment with placebo to treatment with RUCONEST (R).
In the intent-to-treat analysis (ITT), the study found a statistically significant difference in the mean number of HAE attacks that patients experienced during treatment with both the twice-weekly (p-value