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news.Santarus, a specialty biopharmaceutical company, has released results from two randomised placebo-controlled clinical trials assessing RHUCIN (recombinant human C1 inhibitor, or rhC1INH).
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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 in patients with Hereditary Angioedema (HAE).
Zuraw et al reported the pooled results of two similar but independent, randomised, placebo-controlled studies in 70 HAE patients.
RHUCIN significantly reduced the time to beginning of relief of symptoms for all anatomical locations studied at both dosage strengths compared to placebo, Santarus said.
Both of the studies were halted, as advised by the respective Independent Data Monitoring Committees, when predefined interim analyses revealed significant results for the primary and secondary endpoints with no apparent adverse safety findings.
Santarus recently licensed exclusive rights from Pharming Group to commercialise RHUCIN in North America for the treatment of acute attacks of angioedema in patients with HAE and other future indications.