Santarus, Inc. (NASDAQ:SNTS) and Pharming Group NV (NYSE Euronext: PHARM) announced that new data from an open-label extension of the pivotal Phase III clinical study with RUCONEST ® (recombinant human C1 esterase inhibitor, or rhC1INH) will be featured in a poster presentation on November 9 & 10, 2013 at the 2013 American College of Allergy, Asthma & Immunology Annual Scientific Meeting at the Convention Center in Baltimore, Maryland. The poster is titled, Efficacy and Safety of Recombinant Human C1 Esterase Inhibitor for Acute Attacks of Hereditary Angioedema: An Open-Label Study.
RUCONEST was administered for the treatment of 224 repeat acute angioedema attacks in 44 patients with hereditary angioedema (HAE) following initial treatment in the pivotal randomized controlled clinical study. RUCONEST is an investigational drug in the U.S. and has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of acute attacks of HAE.
“The results from this clinical trial are consistent with findings from previous studies supporting that RUCONEST reduces time to symptom relief when used for repeat HAE attacks,” said H. Henry Li, M.D., Ph.D., Director of Chevy Chase Clinical Research, Institute for Asthma and Allergy, Chevy Chase, Maryland. “In addition, it is important clinically to evaluate the safety findings from these multiple exposures.”
The median time in minutes (95% confidence interval [CI]) to onset of symptom relief following treatment as measured by patient responses to a Treatment Effect Questionnaire (TEQ) for the first five repeat attacks ranged from 62.5 (48, 90) to 134.0 (75, 150) and across all attacks was a median of 75.0 (69, 89). The median (95% CI) time in minutes to minimal symptoms (first three attacks per patient) as measured by a TEQ ranged from 243 (76, 1440) to 304 (150, 719) and for all assessed attacks was 303 (211, 367).