Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical company, today announced the publication of an integrated analysis of two randomized placebo-controlled clinical trials with RHUCIN® (recombinant human C1 inhibitor, or rhC1INH), in the October issue of the peer reviewed Journal of Allergy and Clinical Immunology (JACI). The studies were conducted to evaluate the efficacy and safety of two dosage strengths of RHUCIN, an investigational drug, for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE). HAE is a human genetic disorder in which the patient is deficient in or lacks a functional plasma protein C1 inhibitor, resulting in an overreaction of the immune system.
“The publication of the results from these randomized controlled trials is an important step in educating the medical community about recombinant human C1INH for HAE patients with acute angioedema.”
In the JACI publication, Zuraw et al reported the pooled results of two similar but independent, randomized, placebo-controlled studies in 70 HAE patients. As advised by the respective Independent Data Monitoring Committees, both of the studies were halted when predefined interim analyses revealed statistically significant results for the primary and secondary endpoints with no apparent adverse safety findings.
RHUCIN significantly reduced the time to beginning of relief of symptoms for all anatomical locations studied at both dosage strengths compared to placebo. The mean overall score on the visual analogue scale for both RHUCIN groups decreased more rapidly than that of the placebo group. Treatment with RHUCIN 100 U/kg>
RHUCIN treatment was well tolerated in the studies. No patient was discontinued due to an adverse reaction. Adverse events occurred less frequently in the RHUCIN groups (27 adverse events in 7 patients treated with 100 U/kg and 6 adverse events in 4 patients of the 50 U/kg group) than in the placebo group (33 adverse events in 14 patients). Adverse events that were assessed as related to study treatment for patients exposed to RHUCIN included headache and vertigo; adverse events that were assessed as related to patients receiving placebo were headache, injection site swelling, epistaxis and hypotension. One serious adverse event occurred in the 100 U/kg (31 days following treatment) and three in the placebo group. None of the serious adverse events were considered by the investigator to be possibly, probably or definitely related to study drug.
Lead author Bruce Zuraw, M.D., said, "The publication of the results from these randomized controlled trials is an important step in educating the medical community about recombinant human C1INH for HAE patients with acute angioedema." Dr. Zuraw is a leading authority on HAE and is Professor of Medicine and Chief, Section of Allergy & Immunology in the Department of Medicine, University of California, San Diego and Research Scientist at the Veterans Medical Research Foundation, San Diego, CA.
Santarus recently licensed exclusive rights from Pharming Group NV to commercialize RHUCIN in North America for the treatment of acute attacks of angioedema in patients with HAE and other future indications.
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